Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0417-05

Video cart shelf system for organizing with three styles: standard, multispecialty, and auxiliary. Isolation...

Stryker Corp. / initiated 2004-11-30 / Terminated / root cause: design

Stryker Endoscopy began a recall of Video cart shelf system for organizing with three styles: standard, multispecialty, and auxiliary. Isolation Transformer provides power to devices, also sold... on . The reason FDA records is "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". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-0417-05
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Stryker Corp.
Product
Video cart shelf system for organizing with three styles: standard, multispecialty, and auxiliary. Isolation Transformer provides power to devices, also sold separately.
Product code
GCJ Laparoscope, General & Plastic Surgery
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.
Root cause tag
design
FDA root cause
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.
Product codes and lots
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