Recall Z-1440-2013— Carl Zeiss Meditec, Inc.
Class II · Terminated
Class II FDA medical device recall by Carl Zeiss Meditec, Inc., initiated 2013-04-18, terminated 2013-06-26. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..
- Recalling firm
- Carl Zeiss Meditec, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-04-18
- Terminated
- 2013-06-26
- Firm location
- Dublin, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.