Carl Zeiss Meditec, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1440-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.
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.

Product Classification:

Class II

Date Initiated: April 18, 2013
Date Posted: June 12, 2013
Recall Number: Z-1440-2013
Event ID: 65109
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.

Status: Terminated
Product Quantity: 6 units
Code Information:

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

Distribution Pattern:

US Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated