Z-0906-2011

InfraVision IR Illuminator Console, model number 220-180-521, manufactured by Stryker Endoscopy San Jose, for...

Name: Z-0906-2011 InfraVision IR Illuminator Console, model number 220-180-521, manufactured by Stryker Endoscopy San Jose, for...
Creator: Stryker Endoscopy
Published: 2010-09-29
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2010-09-29 / Terminated / root cause: manufacturing process

FDA source

Stryker Endoscopy began a recall of InfraVision IR Illuminator Console, model number 220-180-521, manufactured by Stryker Endoscopy San Jose, for use with the Stryker InfraVision system. Intended... on 2010-09-29. The reason FDA records is "Product may not adequately visualize IR light emitted from U- and E- kits due to a manufacturing error". 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-0906-2011
Status: Terminated
Initiated: 2010-09-29
Posted: 2011-01-18
Terminated: 2011-02-09
Recalling firm: Stryker Corp.
Product: InfraVision IR Illuminator Console, model number 220-180-521, manufactured by Stryker Endoscopy San Jose, for use with the Stryker InfraVision system. Intended use:Medical device for human use, during surgical procedures to transilluminate anatomical structures during surgical procedures with infrared light. It can be used in either open surgical interventions or during laparoscopic procedures. infrared light which is not visible to the human eye is detected by all of Stryker's infrared sensitive cameras. The InfraVision console outputs the infrared light via disposable fibers hooked to the console that are contained in either the E-kit or the U-kit.
Product code: FGS Carrier, Sponge, Endoscopic
Reason for recall: Product may not adequately visualize IR light emitted from U- and E- kits due to a manufacturing error.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, Stryker Endoscopy, sent an "Urgent: Device Correction" letter dated September 28, 2010, t o all consignees/customers via a Fed Ex Mailer that included notification letter, acknowledgment receipts and updated instructions for use. International Stryker sites received product advisory notification. Stryker reps at those sites are responsible for notifying customers. The letter described the product, problem and actions to be taken by the customers. The customers were instructed to discard any old IFUs from the InfraVision Console and ensure that they only use InfraVision compatible scopes; read the newly updated IFU provided with the letter; and complete and sign the enclosed "acknowledgement of receipt" form and fax to (408) 754-8378 or scan in or email to [email protected]. Note: Not returning the "acknowledgement of receipt" card will result in additional notices. Please contact your local Stryker sales representative to obtain information on scopes that are specific to the InfraVision system. If you have any questions, please contact us at 1-800-624-4422 or email at [email protected].
Quantity in commerce: 861 units.
Distribution: Worldwide distribution: USA and countries including: Australia, Africa, Brazil, Canada, China, France, Greece, India, Italy, Korea, Latin America Mexico, New Zealand, Portugal, Romania, Singapore, Sweden, Switzerland, Taiwan, Thailand, and United Kingdom.
Product codes and lots: All lots and serial numbers are affected.

Product code FGS

K945297Class IIInfra Vision Imaging SystemGabriel Medical, Inc. / cleared 1994-12-20

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)