FDAFDA · Food and drugs·Recall number Z-1440-2013
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.
Published June 12, 2013 · Recall initiated: April 18, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Carl Zeiss Meditec, Inc.
- Distributor
- US Nationwide Distribution.
- Lot
- Serial Numbers: 6725000708, 6725000709, 6725000710, 6725000713, 6725100725, 6725120813
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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