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SEDECAL
Model SM-40HF-Batt · SEDECAL · DI 08436046001114
IZL — System, X-Ray, Mobile · Class II · 21 CFR 892.1720
MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager) · Class II · 21 CFR 892.1680
UDILibrary device dossier · generated 2026-09-13 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (31)
| Initiated | Recall # | Class | Status | Reason | Link basis |
|---|---|---|---|---|---|
| 2025-06-10 | Z-0253-2026 | Class II | Open, Classified | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | k number procode |
| 2025-06-10 | Z-0254-2026 | Class II | Open, Classified | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | k number procode |
| 2025-06-10 | Z-0255-2026 | Class II | Open, Classified | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | k number procode |
| 2025-06-10 | Z-0256-2026 | Class II | Open, Classified | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | k number procode |
| 2025-06-10 | Z-0257-2026 | Class II | Open, Classified | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | k number procode |
| 2025-06-10 | Z-0258-2026 | Class II | Open, Classified | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | k number procode |
| 2025-06-10 | Z-0259-2026 | Class II | Open, Classified | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | k number procode |
| 2025-06-10 | Z-0260-2026 | Class II | Open, Classified | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | k number procode |
| 2025-06-10 | Z-0261-2026 | Class II | Open, Classified | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | code info di |
| 2025-06-10 | Z-0262-2026 | Class II | Open, Classified | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | k number procode |
| 2025-06-10 | Z-0263-2026 | Class II | Open, Classified | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | k number procode |
| 2025-06-10 | Z-0264-2026 | Class II | Open, Classified | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | k number procode |
| 2025-06-10 | Z-0265-2026 | Class II | Open, Classified | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | k number procode |
| 2025-06-10 | Z-0266-2026 | Class II | Open, Classified | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | k number procode |
| 2025-06-10 | Z-0267-2026 | Class II | Open, Classified | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | k number procode |
| 2025-06-10 | Z-0268-2026 | Class II | Open, Classified | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | k number procode |
| 2025-06-10 | Z-0269-2026 | Class II | Open, Classified | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | k number procode |
| 2025-06-10 | Z-0270-2026 | Class II | Open, Classified | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | k number procode |
| 2025-06-10 | Z-0271-2026 | Class II | Open, Classified | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | k number procode |
| 2025-06-10 | Z-0272-2026 | Class II | Open, Classified | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | k number procode |
| 2025-06-10 | Z-0273-2026 | Class II | Open, Classified | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | k number procode |
| 2025-06-10 | Z-0274-2026 | Class II | Open, Classified | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | k number procode |
| 2025-06-10 | Z-0275-2026 | Class II | Open, Classified | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | k number procode |
| 2025-06-10 | Z-0277-2026 | Class II | Open, Classified | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | k number procode |
| 2025-06-10 | Z-0278-2026 | Class II | Open, Classified | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | k number procode |
| 2025-06-10 | Z-0279-2026 | Class II | Open, Classified | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | k number procode |
| 2025-06-10 | Z-0280-2026 | Class II | Open, Classified | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | k number procode |
| 2025-06-10 | Z-0282-2026 | Class II | Open, Classified | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | k number procode |
| 2025-06-10 | Z-0283-2026 | Class II | Open, Classified | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | k number procode |
| 2025-06-10 | Z-0286-2026 | Class II | Open, Classified | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | k number procode |
| 2025-06-10 | Z-0287-2026 | Class II | Open, Classified | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | k number procode |
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1 |
| 2019-02 | 0 | 2 |
| 2019-03 | 0 | 2 |
| 2019-04 | 0 | 3 |
| 2019-05 | 0 | 1 |
| 2019-06 | 0 | 2 |
| 2019-07 | 0 | 1.67 |
| 2019-08 | 0 | 1.5 |
| 2019-09 | 0 | 1.5 |
| 2019-10 | 0 | 1 |
| 2019-12 | 0 | 3.5 |
| 2020-01 | 0 | 1.33 |
| 2020-02 | 0 | 1 |
| 2020-03 | 0 | 1 |
| 2020-04 | 0 | 1.67 |
| 2020-06 | 0 | 2 |
| 2020-08 | 0 | 1.5 |
| 2020-09 | 0 | 1.5 |
| 2020-10 | 0 | 2 |
| 2020-12 | 0 | 2.25 |
| 2021-01 | 0 | 2.75 |
| 2021-02 | 0 | 1.67 |
| 2021-03 | 0 | 1.67 |
| 2021-04 | 0 | 2 |
| 2021-05 | 0 | 1.29 |
| 2021-06 | 0 | 1.5 |
| 2021-07 | 0 | 2 |
| 2021-08 | 0 | 1.25 |
| 2021-09 | 0 | 1 |
| 2021-10 | 0 | 2 |
| 2021-11 | 0 | 2 |
| 2021-12 | 0 | 1.33 |
| 2022-01 | 0 | 2 |
| 2022-02 | 0 | 3 |
| 2022-03 | 0 | 2 |
| 2022-04 | 0 | 1.5 |
| 2022-05 | 0 | 1.75 |
| 2022-06 | 0 | 1.38 |
| 2022-07 | 0 | 6 |
| 2022-09 | 0 | 1 |
| 2022-10 | 0 | 2 |
| 2022-11 | 0 | 3.5 |
| 2022-12 | 0 | 2 |
| 2023-01 | 0 | 2.33 |
| 2023-02 | 0 | 1.5 |
| 2023-03 | 0 | 2.25 |
| 2023-04 | 0 | 1.82 |
| 2023-05 | 0 | 1.8 |
| 2023-06 | 0 | 4.43 |
| 2023-07 | 0 | 2.75 |
| 2023-08 | 0 | 1.86 |
| 2023-09 | 0 | 2.67 |
| 2023-10 | 0 | 2.33 |
| 2023-11 | 0 | 2.33 |
| 2023-12 | 0 | 2.67 |
| 2024-01 | 0 | 3.5 |
| 2024-02 | 0 | 2.25 |
| 2024-03 | 0 | 3 |
| 2024-04 | 0 | 5.4 |
| 2024-05 | 0 | 2.6 |
| 2024-06 | 0 | 1.14 |
| 2024-07 | 0 | 2 |
| 2024-08 | 0 | 2.14 |
| 2024-09 | 0 | 3.25 |
| 2024-10 | 0 | 4.5 |
| 2024-11 | 0 | 3.75 |
| 2024-12 | 0 | 2.33 |
| 2025-01 | 0 | 3.8 |
| 2025-02 | 0 | 5 |
| 2025-03 | 0 | 2.56 |
| 2025-04 | 0 | 2 |
| 2025-05 | 0 | 2.83 |
| 2025-06 | 0 | 2.67 |
| 2025-07 | 0 | 3 |
| 2025-08 | 0 | 3.5 |
| 2025-09 | 0 | 1.67 |
| 2025-10 | 0 | 1.33 |
| 2025-11 | 0 | 2.73 |
| 2025-12 | 0 | 4.25 |
| 2026-01 | 0 | 1 |
| 2026-02 | 0 | 2.95 |
| 2026-03 | 0 | 2.2 |
| 2026-04 | 0 | 2.59 |
| 2026-05 | 0 | 2.28 |
| 2026-06 | 0 | 4.23 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K090322 — cited as predicate by K103597, K111725, K142492
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — SEDECAL
- OAI 2025-01-24 SEDECAL SA · 4 citations
- VAI 2013-06-28 SEDECAL SA · 2 citations
- NAI 2010-01-15 SEDECAL SA · 0 citations