GE OEC InstaTrak 3500 Carts Recalled for Tipping Hazard
GE Healthcare is recalling 99 OEC InstaTrak 3500 Carts because the imaging arm may cause the cart to tip over during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involves a risk-of-harm product (tipping hazard) where injury has not yet been reported, which aligns with the High severity criteria in the rubric.
Plain-English summary
GE Healthcare is recalling 99 units of the OEC InstaTrak 3500 Carts. These devices are picture archiving and communications systems intended to help locate anatomical structures during open percutaneous surgical procedures. The recall is due to a potential hazard where the cart may tip over when the arm of the imaging device is extended during use.
The affected units are identified by model number A857680 with various serial numbers. The products were distributed nationwide. The source text does not specify the number of reported injuries or illnesses associated with this defect.
Consumers and healthcare facilities should stop using the affected carts and contact GE OEC Medical Systems, Inc. for further instructions on the recall.
The recalled product
- Product
- OEC InstaTrak 3500, picture archiving and communications system intended as an aid to locate anatomical structures during open percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgical technique. The…
- Manufacturer
- GE OEC Medical Systems, Inc
- Hazard
- Affected units
- 99
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)
- Model number A857680 with various serial numbers (refer to consignee list).
Distribution
Distributed nationwide across the United States.
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