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U.S. Department of Health and Human Services

Class 2 Device Recall InfraVision IR Illuminator Console

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  Class 2 Device Recall InfraVision IR Illuminator Console see related information
Date Initiated by Firm September 29, 2010
Date Posted January 18, 2011
Recall Status1 Terminated 3 on February 09, 2011
Recall Number Z-0906-2011
Recall Event ID 56871
510(K)Number K945297  
Product Classification Carrier, sponge, endoscopic - Product Code FGS
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.
Code Information All lots and serial numbers are affected.
Recalling Firm/
Manufacturer		 Stryker Endoscopy
5900 Optical Ct
San Jose CA 95138-1400
For Additional Information Contact Michael Hilldoerfer
408-754-2664
Manufacturer Reason
for Recall		 Product may not adequately visualize IR light emitted from U- and E- kits due to a manufacturing error.
FDA Determined
Cause 2		 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 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.
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FGS and Original Applicant = GABRIEL MEDICAL, INC.
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