Adverse-event reports (MAUDE)
Read this first: 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 shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
7 linked reportsInjury 7
| 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 | 7 | 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 |
Failure-mode summaryAI-generated
7 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2025-06-10 | Z-0243-2026 | 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.Distribution: US: CA, IL, and NJ | 1198 units | code info di |
| 2024-01-22 | Z-1754-2024 | Class II | Open, Classified | Potential interference with the anti-fall system.Distribution: Worldwide distribution - US Nationwide in the states of CA, IL, NJ, and areas yet to be identified by Philips Medical Systems DMC GmbH, Hamburg, Germany. | 636 devices | code info di |
| 2021-10-14 | Z-1083-2024 | Class II | Open, Classified | While cleaning or disinfecting the system, if the process is not followed as described in the manual and excessive liquid is used or sprayed directly on the system, it could cause a short circuit of the fine positioning control button. This would result in the system moving on its own in a very slow speed forward circular motion.Distribution: US Nationwide distribution. There was government distribution but no military distribution. | 851 devices | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2023-06-23 | 3016618143-2023-00007 | Injury | Available | exact di |
| 2023-06-23 | 3016618143-2023-00001 | Injury | Available | exact di |
| 2023-06-23 | 3016618143-2023-00004 | Injury | Available | exact di |
| 2023-06-23 | 3016618143-2023-00006 | Injury | Available | exact di |
| 2023-06-23 | 3016618143-2023-00005 | Injury | Available | exact di |
| 2023-06-23 | 3016618143-2023-00002 | Injury | Available | exact di |
| 2023-06-23 | 3016618143-2023-00003 | Injury | Available | exact di |
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2025-01-24 | OAI | Official action indicated | SEDECAL SA | 4 |
| 2013-06-28 | VAI | Voluntary action indicated | SEDECAL SA | 2 |
| 2010-01-15 | NAI | No action indicated | SEDECAL SA | 0 |
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