RecallRadar

FDA Device recall Z-1440-2013

Zeiss brand OPMI Pentero C, Surgical microscope and accessories, Model: OPMI Pentero C, Product Numbers: 302583-9001-000 (PENTERO C), and 3…

On 2013-06-12 the FDA classified a Class II recall of Zeiss brand OPMI Pentero C, Surgical microscope and accessories, Model: OPMI Pentero C, Product Numbers: 302583-9001-000 (PENTERO C), and 3… by Carl Zeiss Meditec, citing 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….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1440-2013
ClassificationClass II
Statusterminated
Initiated2013-04-18
Published2013-06-12
Last updated2026-09-13 11:53 UTC
CompanyCarl Zeiss Meditec
DistributionUS

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.

Identifiers

code_infoSerial Numbers: 6725000708, 6725000709, 6725000710, 6725000713, 6725100725, 6725120813

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1440-2013%22

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