—#94756

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.

FDA product code: FGS — Carrier, Sponge, Endoscopic
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K945297
Affected lot / code info: All lots and serial numbers are affected.

Why it was recalled

Product may not adequately visualize IR light emitted from U- and E- kits due to a manufacturing error.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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 infravision@stryker.com. 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 infravision@stryker.com.

Recalling firm

Firm: Stryker Endoscopy
Address: 5900 Optical Ct, San Jose, California 95138-1400

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2010-09-29
Posted by FDA: 2011-01-18
Terminated: 2011-02-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #94756. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.