Z-1440-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 12, 2013
- Initiation Date
- April 18, 2013
- Termination Date
- June 26, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 units
Product Description
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.
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.
Distribution Pattern
US Nationwide Distribution.
Code Information
Serial Numbers: 6725000708, 6725000709, 6725000710, 6725000713, 6725100725, 6725120813