—#36549

Product

Video cart shelf system for organizing with three styles: standard, multispecialty, and auxiliary. Isolation Transformer provides power to devices, also sold separately.

FDA product code: GCJ — Laparoscope, General & Plastic Surgery
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K935234
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: The products were distributed to 114 consignees.

Timeline

Recall initiated: 2004-11-30
Posted by FDA: 2005-01-27
Terminated: 2005-05-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #36549. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.