GE OEC 9900 Elite Surgical Carts Recalled for Documentation Updates
GE Healthcare is updating user documentation for OEC 9900 Elite surgical carts to clarify maintenance and component replacement frequencies.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is a voluntary field action for documentation updates regarding maintenance frequencies, which aligns with the rubric for documentation issues or packaging-only problems.
Plain-English summary
GE Healthcare Surgery has announced a voluntary field action for the OEC 9800 and OEC 9900 Elite surgical carts. The action involves supplementing the user documentation to include specific areas for enhanced planned maintenance and component replacement frequencies.
The affected units were manufactured from October 2005 to the present. A total of 26,256 units are involved in this field action. Distribution was worldwide, including government, VA, military, and foreign consignees.
This action is a documentation update intended to ensure proper maintenance schedules are followed. No specific safety hazards or injuries are reported in the source text.
The recalled product
- Product
- OEC 9900 Elite. MDL Numbers: D148942, D155043
- Manufacturer
- GE OEC Medical Systems, Inc
- Category
- Medical Device — Surgical Carts
- Hazard
- Affected units
- 26,256
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Manufactured from Oct 2005 to present
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by GE OEC Medical Systems, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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