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Ave 2
L I N E T spol. s r.o. · Model 4BCPPB-CCZ0008 · UDI-DI 08592654800829
7
510(k) clearances
4,666
Adverse events (2 deaths)
8
Recalls
10
Facilities
Description
Electrical Birthing bed
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-03-06 | Linet Americas | The UDI on the device label indicates incorrect manufacturer. |
| 2019-01-07 | Linet Spol. S.r.o. | LINET has recently become aware of a potential safety issue for the AVE 2 Birthing Bed caused by the power cable breaking at the bed connection or the orange insulation of the powe |
| 2009-11-16 | Hill-Rom, Inc. | The brakes may not hold or lock. |
| 2007-09-06 | Hill-Rom, Inc. | Brake failure: The brakes may not hold or lock properly. |
| 2005-03-31 | Stryker Medical | Trendelenburg and reverse trendelenburg features may not function. |
| 2004-01-26 | Stryker Medical | A potential shock hazard exists if the night light is damaged. |
| 2004-01-26 | Stryker Medical | A potential shock hazard exists if the night light is damaged. |
| 2004-01-26 | Stryker Medical | A potential shock hazard exists if the night light is damaged. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.