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U.S. Department of Health and Human Services

Class 3 Device Recall Stryker Video Cart with Isolation Transformer

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  Class 3 Device Recall Stryker Video Cart with Isolation Transformer see related information
Date Initiated by Firm November 30, 2004
Date Posted January 27, 2005
Recall Status1 Terminated 3 on May 13, 2005
Recall Number Z-0417-05
Recall Event ID 30763
510(K)Number K935234  
Product Classification Laparoscope, General & Plastic Surgery - Product Code GCJ
Product Video cart shelf system for organizing with three styles: standard, multispecialty, and auxiliary. Isolation Transformer provides power to devices, also sold separately.
Code Information Model numbers 240-099-011- Serial numbers 031111001-021, 040114001-029, 040130001-007, 040308001-023, 040322001-010, 040412001-020. 240-099-012- serial numbers 040130008-022, 040311001-015, 040322001-010, 040401001, 002, 004 and 005. 240-099-020-serial numbers 040212001-032, 040309001-007, 040313001-010. 240-099-021-serial numbers 040224001-021, 040313017. 240-099-050-serial numbers 031218001-005, 031218031-045
Recalling Firm/
Manufacturer		 Stryker Endoscopy
5900 Optical Ct
San Jose CA 95138-1400
Manufacturer Reason
for Recall		 A problem with the design of the transformers may cause the transformers' circuit breakers to trip, which could result in loss of power to connected medical devices.
FDA Determined
Cause 2		 Device Design
Action The firm has initiated consignee notification by sending a notification letter and acknowledgement of receipt cards to its consignees. Service cards will be issued to firm sales representatives.
Quantity in Commerce 256 carts with transformers, 20 transformers
Distribution The products were distributed to 114 consignees.
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 = GCJ and Original Applicant = Stryker Endoscopy
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