Recall Z-1440-2013 ยท EPT Microscope, Surgical
Carl Zeiss Meditec, Inc.
Zeiss brand OPMI Pentero C, Surgical microscope and accessories, Model: OPMI Pentero C, Product Numbers: 302583-9001-000 (PENTERO C), and 305961-0000-00 (Ceiling Mount for PENTERO C), Product Usage: A surgical microscope and accessories is an AC-powered device intended for use during surgery to provide a magnified view of the surgical field.
| Date | May 31, 2013 (initiated Apr 18, 2013) |
| Status | Terminated |
| Reason | Carl Zeiss Meditec is conducting a field corrective action for its OPMI Pentero C surgical microscope system. During a routine inspection, one microscope installation was found to have 3 (three) broken screws out of 6 (six) in the lower section of the ceiling mount. |
| Root cause | Under Investigation by firm |
| Action | Carl Zeiss Meditec, Inc sent a Customer Notification letter to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter stated that firm's sales representative will be scheduling an on-site visit, informing them of the affected product and providing instructions on the recall. For question call 925-580-5371. |
| Quantity | 6 units |
| Distribution | US Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.