GE OEC 9900 Elite C-arm System Recalled for Power Supply Defect
GE OEC recalled 726 OEC 9900 Elite C-arm systems worldwide due to a defective vertical lift column power supply identified during an FDA inspection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the defect involves a mechanical component subject to early life failure in a surgical device, representing a risk of harm where injury has not yet been reported.
Plain-English summary
GE OEC Medical Systems, Inc. is recalling 726 units of the OEC 9900 Elite, OEC 9900 Elite MD Motorized C-arm System, and OEC 9900 Elite NAV. These imaging devices are used to locate anatomical structures during open or percutaneous surgical procedures. The affected units were distributed worldwide.
The recall was initiated following an FDA inspection that identified a defect in the vertical lift column power supply within the mainframe C-arm. This component is subject to early life failure. The recall covers specific part numbers, including 00-887200-01, 00-887200-03, 00-887201-01, 00-887201-03, 00-887202-01, 00-887202-03, 00-887204-03, 00-887207-03, and 00-887206-03, along with all associated serial numbers.
This notice clarifies that the firm has already taken action, but the recall is now being formally classified by the Agency due to administrative issues. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.
The recalled product
- Product
- OEC 9900 Elite, OEC 9900 Elite MD Motorized C-arm System, OEC 9900 Elite NAV used as an aid to locate anatomical structures during open or percutaneous surgical procedures. The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It
- Manufacturer
- GE OEC Medical Systems, Inc
- Hazard
- Affected units
- 726
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 (9)
- Part numbers: 00-887200-01
- 00-887200-03
- 00-887201-01
- 00-887201-03
- 00-887202-01
- 00-887202-03
- 00-887204-03
- 00-887207-03
- 00-887206-03. Along with all associated serial numbers.
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 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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