Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

A7 Multi Gas Module with Accessory Kit

Model 115-016575-00 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · DI 06944904084251

BSZ — Gas-Machine, Anesthesia · Class II · 21 CFR 868.5160

UDILibrary device dossier · generated 2026-09-16 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (3)

InitiatedRecall #ClassStatusReasonLink basis
2017-07-14Z-0847-2018Class IITerminatedA software issue may result in the previous settings being applied instead of the default settings or the unit may skip the startup leak test.k number procode
2016-08-04Z-2692-2016Class IITerminatedBeckman Coulter is recalling the UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System to reduce the potential for flammable liquids coming into contact with electrical components in the Stainer module possibly causing a fire.k number procode
2016-06-15Z-2689-2016Class IITerminatedPotential for a leak to occur on the back-up O2 and air e-size cylinder yokes on the A7 Anesthesia Delivery System.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.

173552692019-01: 0 reports for this device; peer average 2.5/device2019-02: 0 reports for this device; peer average 4.67/device2019-03: 0 reports for this device; peer average 4.5/device2019-04: 0 reports for this device; peer average 7.08/device2019-05: 0 reports for this device; peer average 3.75/device2019-06: 0 reports for this device; peer average 2.8/device2019-07: 0 reports for this device; peer average 7.5/device2019-08: 0 reports for this device; peer average 2.5/device2019-09: 0 reports for this device; peer average 15.7/device2019-10: 0 reports for this device; peer average 9.18/device2019-11: 0 reports for this device; peer average 5.11/device2019-12: 0 reports for this device; peer average 8.57/device2020-01: 0 reports for this device; peer average 5.14/device2020-02: 0 reports for this device; peer average 5/device2020-03: 0 reports for this device; peer average 7.86/device2020-04: 0 reports for this device; peer average 5.8/device2020-05: 0 reports for this device; peer average 3/device2020-06: 0 reports for this device; peer average 2.57/device2020-07: 0 reports for this device; peer average 5.13/device2020-08: 0 reports for this device; peer average 6.71/device2020-09: 0 reports for this device; peer average 6.83/device2020-10: 0 reports for this device; peer average 5.78/device2020-11: 0 reports for this device; peer average 6.86/device2020-12: 0 reports for this device; peer average 6.88/device2021-01: 0 reports for this device; peer average 7.14/device2021-02: 0 reports for this device; peer average 5/device2021-03: 0 reports for this device; peer average 10.57/device2021-04: 0 reports for this device; peer average 8.71/device2021-05: 0 reports for this device; peer average 5.71/device2021-06: 0 reports for this device; peer average 6.11/device2021-07: 0 reports for this device; peer average 3.71/device2021-08: 0 reports for this device; peer average 7/device2021-09: 0 reports for this device; peer average 6/device2021-10: 0 reports for this device; peer average 6.83/device2021-11: 0 reports for this device; peer average 6.83/device2021-12: 0 reports for this device; peer average 6.3/device2022-01: 0 reports for this device; peer average 4.57/device2022-02: 0 reports for this device; peer average 4.86/device2022-03: 0 reports for this device; peer average 9.57/device2022-04: 0 reports for this device; peer average 8.11/device2022-05: 0 reports for this device; peer average 8.38/device2022-06: 0 reports for this device; peer average 23.4/device2022-07: 0 reports for this device; peer average 16.14/device2022-08: 0 reports for this device; peer average 13/device2022-09: 0 reports for this device; peer average 16.57/device2022-10: 0 reports for this device; peer average 12.63/device2022-11: 0 reports for this device; peer average 10.88/device2022-12: 0 reports for this device; peer average 9.27/device2023-01: 0 reports for this device; peer average 9/device2023-02: 0 reports for this device; peer average 12.5/device2023-03: 0 reports for this device; peer average 7.86/device2023-04: 0 reports for this device; peer average 7.9/device2023-05: 0 reports for this device; peer average 8.58/device2023-06: 0 reports for this device; peer average 11.89/device2023-07: 0 reports for this device; peer average 9.67/device2023-08: 0 reports for this device; peer average 10.55/device2023-09: 0 reports for this device; peer average 14.3/device2023-10: 0 reports for this device; peer average 21.35/device2023-11: 0 reports for this device; peer average 19.22/device2023-12: 0 reports for this device; peer average 22.15/device2024-01: 0 reports for this device; peer average 9.08/device2024-02: 0 reports for this device; peer average 10.15/device2024-03: 0 reports for this device; peer average 18.25/device2024-04: 0 reports for this device; peer average 20.53/device2024-05: 0 reports for this device; peer average 19.28/device2024-06: 0 reports for this device; peer average 20.83/device2024-07: 0 reports for this device; peer average 20.3/device2024-08: 0 reports for this device; peer average 22.25/device2024-09: 0 reports for this device; peer average 21.04/device2024-10: 0 reports for this device; peer average 25.22/device2024-11: 0 reports for this device; peer average 26.25/device2024-12: 0 reports for this device; peer average 21.05/device2025-01: 0 reports for this device; peer average 23.68/device2025-02: 0 reports for this device; peer average 19.05/device2025-03: 0 reports for this device; peer average 28.65/device2025-04: 0 reports for this device; peer average 48.27/device2025-05: 0 reports for this device; peer average 69.36/device2025-06: 0 reports for this device; peer average 56.35/device2025-07: 0 reports for this device; peer average 48.93/device2025-08: 0 reports for this device; peer average 35.75/device2025-09: 0 reports for this device; peer average 33.3/device2025-10: 0 reports for this device; peer average 34.56/device2025-11: 0 reports for this device; peer average 33.71/device2025-12: 0 reports for this device; peer average 48.9/device2026-01: 0 reports for this device; peer average 35.25/device2026-02: 0 reports for this device; peer average 54.15/device2026-03: 0 reports for this device; peer average 38.83/device2026-04: 0 reports for this device; peer average 49.1/device2026-05: 0 reports for this device; peer average 46.68/device2026-06: 0 reports for this device; peer average 38.65/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.5
2019-0204.67
2019-0304.5
2019-0407.08
2019-0503.75
2019-0602.8
2019-0707.5
2019-0802.5
2019-09015.7
2019-1009.18
2019-1105.11
2019-1208.57
2020-0105.14
2020-0205
2020-0307.86
2020-0405.8
2020-0503
2020-0602.57
2020-0705.13
2020-0806.71
2020-0906.83
2020-1005.78
2020-1106.86
2020-1206.88
2021-0107.14
2021-0205
2021-03010.57
2021-0408.71
2021-0505.71
2021-0606.11
2021-0703.71
2021-0807
2021-0906
2021-1006.83
2021-1106.83
2021-1206.3
2022-0104.57
2022-0204.86
2022-0309.57
2022-0408.11
2022-0508.38
2022-06023.4
2022-07016.14
2022-08013
2022-09016.57
2022-10012.63
2022-11010.88
2022-1209.27
2023-0109
2023-02012.5
2023-0307.86
2023-0407.9
2023-0508.58
2023-06011.89
2023-0709.67
2023-08010.55
2023-09014.3
2023-10021.35
2023-11019.22
2023-12022.15
2024-0109.08
2024-02010.15
2024-03018.25
2024-04020.53
2024-05019.28
2024-06020.83
2024-07020.3
2024-08022.25
2024-09021.04
2024-10025.22
2024-11026.25
2024-12021.05
2025-01023.68
2025-02019.05
2025-03028.65
2025-04048.27
2025-05069.36
2025-06056.35
2025-07048.93
2025-08035.75
2025-09033.3
2025-10034.56
2025-11033.71
2025-12048.9
2026-01035.25
2026-02054.15
2026-03038.83
2026-04049.1
2026-05046.68
2026-06038.65
This device (reports/month)Average device in BSZ (reports/device/month)

Regulatory clearances

  • K151954 SESE 2015-10-27 (k number procode)

Predicate lineage

K151954 — cites (transitively): K042607 (d1), K142552 (d1), K110213 (d2), K123125 (d2), K123211 (d2), K090233 (d3), K092027 (d3), K093886 (d3), K973895 (d3), K973985 (d3), K051092 (d3), K092449 (d3), K102471 (d3), K023454 (d4), K041775 (d4), K063404 (d4), K081842 (d4), K974176 (d4), K080175 (d4), K081844 (d4) — cited as predicate by K171292, K171311, K201957

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

  • NAI 2017-04-14 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 0 citations
  • VAI 2017-04-14 SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. · 0 citations
  • VAI 2017-04-14 SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. · 0 citations
  • NAI 2017-04-14 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 0 citations
  • VAI 2015-05-15 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 1 citations
  • VAI 2012-04-12 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 5 citations