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.
No adverse-event reports are linked to this device.
Recall history
No recalls linked.
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2025-08-01 | NAI | No action indicated | Hill-Rom, Inc. | 0 |
| 2024-04-12 | NAI | No action indicated | Hill-Rom Inc | 0 |
| 2022-07-29 | VAI | Voluntary action indicated | Hill-Rom, Inc. | 3 |
| 2021-11-19 | VAI | Voluntary action indicated | Hill-Rom Inc | 2 |
| 2017-06-22 | VAI | Voluntary action indicated | Hill-Rom, Inc. | 2 |
| 2014-12-19 | VAI | Voluntary action indicated | Hill-Rom Inc | 2 |
| 2014-09-19 | NAI | No action indicated | Hill-Rom Company Inc. | 0 |
| 2014-05-06 | NAI | No action indicated | Hill-Rom, Inc. | 0 |
| 2014-02-13 | OAI | Official action indicated | Hill-Rom Inc | 8 |
| 2013-01-11 | OAI | Official action indicated | Hill-Rom Inc | 6 |
| 2012-03-02 | WL | Warning Letter | Hill-Rom Inc | — |
| 2011-10-11 | OAI | Official action indicated | Hill-Rom Inc | 0 |
| 2010-09-01 | NAI | No action indicated | Hill-Rom, Inc. | 0 |
| 2010-07-06 | VAI | Voluntary action indicated | Hill-Rom Inc | 2 |
Similar devices
- Air+ STRYKER CORPORATION
- Citadel Arjohuntleigh AB
- Citadel Arjohuntleigh AB
- Citadel Arjohuntleigh AB
- Citadel Arjohuntleigh AB
- Citadel Arjohuntleigh AB
- Citadel Arjohuntleigh AB
- Citadel Arjohuntleigh AB
- Citadel Arjohuntleigh AB
- Citadel Arjohuntleigh AB
- Citadel Arjohuntleigh AB
- Citadel Arjohuntleigh AB
Select up to two to place side-by-side with this device.