GE OEC 9800 Surgical Table Field Action for Documentation Updates
GE Healthcare is updating user documentation for OEC 9800 surgical tables to clarify maintenance and component replacement schedules.
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 schedules, which aligns with the rubric for documentation issues and cosmetic defects.
Plain-English summary
GE Healthcare Surgery has announced a voluntary field action for the OEC 9800 and OEC 9900 Elite surgical tables. This action involves supplementing the user documentation to include specific areas for enhanced planned maintenance and component replacement frequencies.
The affected units were manufactured between February 1998 and the present. The recall covers 26,256 units distributed worldwide, including government, VA, military, and foreign consignees. The MDL numbers for the OEC 9800 are D222250 and D141598.
This field action is administrative in nature, focusing on documentation updates rather than a physical defect or safety hazard. Healthcare facilities should review the updated documentation to ensure compliance with the revised maintenance schedules.
The recalled product
- Product
- OEC 9800. MDL Numbers: D222250, D141598
- Manufacturer
- GE OEC Medical Systems, Inc
- Category
- Medical Device — Surgical Table
- 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 Feb 1998 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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