Zeiss brand OPMI Pentero C, Surgical microscope and accessories, Model: OPMI Pentero C, Product Numbers: 302583-9001-000
FDA device recall Z-1440-2013 · posted 2013-05-31 · Terminated
Recall details
- Recalling firm
- Carl Zeiss Meditec, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- EPT
- Quantity affected
- 6 units
- Distribution
- US Nationwide Distribution.
- Date initiated
- 2013-04-18
- Date posted
- 2013-05-31
- Date terminated
- 2013-06-26
- Location
- Dublin, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.