Recall Z-1465-2022 ยท MTX Microscope And Microscope Accessories, Reproduction, Assisted
Zeiss, Carl Inc
ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000
| Date | Jun 24, 2022 |
| Status | Terminated |
| Reason | An incorrect Unique Device Identification (UDI) label was installed on some ZEISS Axio Observer 5 microscopes. |
| Root cause | Process control |
| Action | On June 24, 2022, the firm notified their US customer of the recall via email. The customer was informed that a Zeiss service technician will contact them to arrange a date for performing a corrective action to eliminate the risk. The UDI label will be replaced. |
| Quantity | 1 US; 2 OUS |
| Distribution | US Nationwide distribution in the state of NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.