Z-1440-2013Class II

Zeiss brand OPMI Pentero C, Surgical microscope and accessories, Model: OPMI Pentero C, Product Numbers...

Name: Z-1440-2013 Zeiss brand OPMI Pentero C, Surgical microscope and accessories, Model: OPMI Pentero C, Product Numbers...
Creator: Carl Zeiss Meditec, Inc.
Published: 2013-04-18
License: https://open.fda.gov/license/

Carl Zeiss Meditec Inc / initiated 2013-04-18 / Terminated

FDA source

Carl Zeiss Meditec, Inc. began a recall of Zeiss brand OPMI Pentero C, Surgical microscope and accessories, Model: OPMI Pentero C, Product Numbers: 302583-9001-000 (PENTERO C), and 305961-0000-00... on 2013-04-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1440-2013
Classification: Class II
Status: Terminated
Initiated: 2013-04-18
Posted: 2013-05-31
Terminated: 2013-06-26
Recalling firm: Carl Zeiss Meditec Inc
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.
Product code: EPT Microscope, Surgical
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.
FDA root cause: Under Investigation by firm
Action: Carl Zeiss Meditec, Inc sent a Customer Notification letter to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter stated that firm's sales representative will be scheduling an on-site visit, informing them of the affected product and providing instructions on the recall. For question call 925-580-5371.
Quantity in commerce: 6 units
Distribution: US Nationwide Distribution.
Product codes and lots: Serial Numbers: 6725000708, 6725000709, 6725000710, 6725000713, 6725100725, 6725120813

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1440-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1440-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-12	2013-05-31

Product code EPT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)