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K-Systems
Coopersurgical, Inc. · Model 6.121.312.121 · UDI-DI 00888937023923
1
510(k) clearances
5
Adverse events
6
Recalls
21
Facilities
Description
L126 IVF, RI Witness Left
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-11-15 | CooperSurgical, Inc. | The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will al |
| 2024-11-15 | CooperSurgical, Inc. | The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will al |
| 2024-11-15 | CooperSurgical, Inc. | The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will al |
| 2024-11-15 | CooperSurgical, Inc. | The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will al |
| 2024-11-15 | CooperSurgical, Inc. | The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will al |
| 2024-11-15 | CooperSurgical, Inc. | The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will al |
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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.