Z-1640-2010

Stryker VISUM LED Surgical Lights (Ceiling Mounted Surgical Light), Catalog numbers: 0682001250, 0682001251...

Name: Z-1640-2010 Stryker VISUM LED Surgical Lights (Ceiling Mounted Surgical Light), Catalog numbers: 0682001250, 0682001251...
Creator: Stryker Communications Corp
Published: 2010-04-15
License: https://open.fda.gov/license/

STRYKER Communications, Inc. / initiated 2010-04-15 / Terminated / root cause: manufacturing process

FDA source

Stryker Communications Corp began a recall of Stryker VISUM LED Surgical Lights (Ceiling Mounted Surgical Light), Catalog numbers: 0682001250, 0682001251. Intended to illuminate the operative site during... on 2010-04-15. The reason FDA records is "Installation records are incomplete". 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-1640-2010
Status: Terminated
Initiated: 2010-04-15
Posted: 2010-05-21
Terminated: 2011-01-24
Recalling firm: STRYKER Communications, Inc.
Product: Stryker VISUM LED Surgical Lights (Ceiling Mounted Surgical Light), Catalog numbers: 0682001250, 0682001251. Intended to illuminate the operative site during surgical procedures with high intensity light.
Product code: FSY Light, Surgical, Ceiling Mounted
Reason for recall: Installation records are incomplete.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: An Urgent: Medical Device Product Correction customer notification letter, dated 4/15/2010, has been sent out to all affected accounts via regular mail in the form of a certified, return request receipt letter. Accounts will receive a follow-up phone call from a Stryker Representative to schedule a re-inspection of equipment to see if it mets established critical specifications or not. The firm recommends that customers continue using all Stryker Communications products listed in the notice. Questions can be directed to Katie Blackwell at 972-410-7660 or via email at [email protected].
Quantity in commerce: 608 (all lights and booms)
Distribution: Nationwide Distribution
Product codes and lots: Product Numbers: Product Installed Between January 2, 2008 and August 31, 2009 Lot Code: Product Installed Between January 1, 2008 and August 31, 2009

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)