The Recall Desk
ModerateFDA (Devices)·Z-1440-2013·Announced 2013-06-12

Zeiss OPMI Pentero C Surgical Microscope Ceiling Mount Recall

Carl Zeiss Meditec is recalling six OPMI Pentero C surgical microscopes because broken screws were found in the ceiling mounts during routine inspections.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source describes a structural defect (broken screws) found during routine inspection without reports of injury or harm, fitting the criteria for a moderate severity precautionary action.

Plain-English summary

Carl Zeiss Meditec, Inc. is conducting a field corrective action for its OPMI Pentero C surgical microscope system. The recall involves six units of the OPMI Pentero C surgical microscope and its associated ceiling mount accessories. The affected product numbers are 302583-9001-000 (PENTERO C) and 305961-0000-00 (Ceiling Mount for PENTERO C). The specific serial numbers affected are 6725000708, 6725000709, 6725000710, 6725000713, 6725100725, and 6725120813.

The recall was initiated after a routine inspection revealed that one microscope installation had three broken screws out of six in the lower section of the ceiling mount. The OPMI Pentero C is an AC-powered device intended for use during surgery to provide a magnified view of the surgical field. The affected units were distributed nationwide in the United States.

Healthcare facilities and users should check their inventory for the specific serial numbers listed above. If a unit is affected, they should contact Carl Zeiss Meditec, Inc. for further instructions on the field corrective action.

The recalled product

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
Affected units
6

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

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

Distribution

Distributed nationwide across the United States.