Zeiss brand OPMI Pentero C…

Date

June 12, 2013

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

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.

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.

Distribution pattern

US Nationwide Distribution.

Quantity

6 units

Codes and lots

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

Recall started

April 18, 2013

Device type

Microscope, Surgical

Root cause (FDA)

Under Investigation by firm

What the company told customers

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.

Recall number

Z-1440-2013

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1440-2013. The agency record governs; check it and the company before acting.