FDA Recall Terminated

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.

Recall: Z-1440-2013 · Initiated April 18, 2013

Recall

Recall Number
Z-1440-2013
Event Number
65109
Firm
Carl Zeiss Meditec, Inc.
FEI Number
2918630
Product Code
EPT
Status
Terminated
Root Cause
Under Investigation by firm
Initiated
April 18, 2013
Posted
May 31, 2013
Terminated
June 26, 2013
Address
5160 Hacienda Dr, Dublin, CA, 94568-7562

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.

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.

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.

Distribution

US Nationwide Distribution.

Quantity

6 units