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 |
|---|---|---|---|---|
| 2025-06-02 | OAI | Official action indicated | American Contract Systems Inc | 4 |
| 2025-04-17 | NAI | No action indicated | American Contract Systems, Inc. | 0 |
| 2025-03-21 | VAI | Voluntary action indicated | American Contract Systems, Inc. | 1 |
| 2025-01-16 | NAI | No action indicated | American Contract Systems Inc. | 0 |
| 2024-11-01 | WL | Warning Letter | American Contract Systems Inc | — |
| 2024-08-14 | OAI | Official action indicated | American Contract Systems Inc | 4 |
| 2022-04-08 | VAI | Voluntary action indicated | American Contract Systems, Inc. | 4 |
| 2022-03-25 | VAI | Voluntary action indicated | American Contract Systems | 4 |
| 2022-03-02 | VAI | Voluntary action indicated | American Contract Systems, Inc. | 4 |
| 2021-12-08 | VAI | Voluntary action indicated | American Contract Systems, Inc. | 0 |
| 2021-12-07 | NAI | No action indicated | American Contract Systems, Inc. | 0 |
| 2021-12-03 | NAI | No action indicated | American Contract Systems, Inc. | 0 |
| 2021-09-24 | VAI | Voluntary action indicated | American Contract Systems Inc. | 0 |
| 2019-11-09 | WL | Warning Letter | American Contract Systems, Inc. | — |
| 2019-10-04 | OAI | Official action indicated | American Contract Systems, Inc. | 5 |
| 2019-09-10 | OAI | Official action indicated | American Contract Systems, Inc. | 3 |
| 2019-08-16 | OAI | Official action indicated | American Contract Systems, Inc. | 8 |
| 2019-07-25 | OAI | Official action indicated | American Contract Systems | 4 |
| 2019-04-01 | NAI | No action indicated | American Contract Systems, Inc. | 0 |
| 2018-11-06 | WL | Warning Letter | American Contract Systems | — |
| 2018-10-02 | OAI | Official action indicated | American Contract Systems | 7 |
| 2018-05-24 | VAI | Voluntary action indicated | American Contract Systems, Inc. | 6 |
| 2017-07-26 | VAI | Voluntary action indicated | American Contract Systems, Inc. | 1 |
| 2011-04-21 | WL | Warning Letter | American Contract Systems Inc | — |
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