Z-0913-2012

Visum LED Surgical Lights, Ceiling Mounted Surgical Light. The Visum LED surgical light is intended to...

Name: Z-0913-2012 Visum LED Surgical Lights, Ceiling Mounted Surgical Light. The Visum LED surgical light is intended to...
Creator: Stryker Communications Corp
Published: 2011-11-07
License: https://open.fda.gov/license/

STRYKER Communications, Inc. / initiated 2011-11-07 / Terminated / root cause: manufacturing process

FDA source

Stryker Communications Corp began a recall of Visum LED Surgical Lights, Ceiling Mounted Surgical Light. The Visum LED surgical light is intended to illuminate the operative site during surgical procedures... on 2011-11-07. The reason FDA records is "Stryker has identified a potential structural issue with the Visum LED surgical light(s). During a complaint investigation, Stryker became aware that there was a possibility that incorrect assembly could result in the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0913-2012
Status: Terminated
Initiated: 2011-11-07
Posted: 2012-01-26
Terminated: 2012-08-17
Recalling firm: STRYKER Communications, Inc.
Product: Visum LED Surgical Lights, Ceiling Mounted Surgical Light. The Visum LED surgical light is intended to illuminate the operative site during surgical procedures with high intensity light.
Product code: FSY Light, Surgical, Ceiling Mounted
Reason for recall: Stryker has identified a potential structural issue with the Visum LED surgical light(s). During a complaint investigation, Stryker became aware that there was a possibility that incorrect assembly could result in the light head beginning to separate from the suspension arm. In the event the light separates and falls from the arm, it could lead to serious injury.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm sent "Urgent: Medical Device Correction" letters dated 11/07/2011 to their domestic and international customers. The letter informed customers of the remote risk of the light detaching from the arm and recommended continued use of the product. A representative will contact them about scheduling an appointment to inspect the lights. Contact Technical Services at 1-866-841-5663 for questions.
Quantity in commerce: 1143 Devices
Distribution: Worldwide Distribution - USA, and the countries of Australia, Canada, Hong Kong, Brazil, Sweden, India, Japan, Korea, Ecuador, Venezuela, Mexico, Denmark, Great Britain, and New Zealand.
Product codes and lots: Catalog Number: 0682001250, 0682001251, 0682001252, and 0682001253. Product Numbers: P10235 (Visum LED Surgical Light, Camera Ready), P10234 (Visum LED Surgical Light), P12875 (Visum LED Surgical Light Camera Ready - Low Ceiling), P12874 (Visum LED Surgical Light - Low Ceiling). Expiration date: There is no expiration date with the scope of the action. Serial Numbers: Product manufactured between October 2010 to July 2011 and in use by customer.

Product code FSY

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)