Reported Jun 12, 2013 · Terminated
Zeiss brand OPMI Pentero C, Surgical microscope and accessories, Model: OPMI Pentero C, Product Numbers:…
Carl Zeiss Meditec, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Carl Zeiss Meditec, Inc. · 5160 Hacienda Dr · Dublin, CA · 94568-7562
Is this the product you have?
- Zeiss brand OPMI Pentero C, Surgical microscope and accessories
- ModelOPMI Pentero C
- Product Numbers302583-9001-000 (PENTERO C), and 305961-0000-00 (Ceiling Mount for PENTERO C)
- Product UsageA surgical microscope and accessories is an AC-powered device intended for use during surgery to provide a magnified view of the surgical field
- Lot codes and dates
- Serial Numbers
672500070867250007096725000710672500071367251007256725120813
- Serial Numbers
- Amount recalled
- 6 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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