GE Healthcare Discovery IGS 740 Systems Recalled for Image Loss
GE Medical Systems is recalling 25 Discovery IGS 740 systems due to potential non-recoverable loss of image acquisition during procedures.
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 high-risk medical device where a functional failure (loss of image acquisition) poses a risk of harm to patients during procedures, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
GE Medical Systems, LLC is recalling 25 units of the GE Healthcare Discovery IGS 740 system. These devices are indicated for use in generating fluoroscopic and rotational images of human anatomy.
The recall is issued because the affected systems may experience multiple X-Ray abort errors before or during a real-time fluoroscopic Interventional procedure. This issue can result in a potential non-recoverable loss of image acquisition.
The affected units were distributed nationwide in the United States and in various countries including Canada, China, France, Germany, and the United Kingdom. Healthcare facilities should contact GE Medical Systems for further instructions regarding the recall.
The recalled product
- Product
- GE Healthcare, Discovery IGS 740. Indicated for use in generating fluoroscopic and rotational images of human anatomy.
- Manufacturer
- GE Medical Systems, LLC
- Affected units
- 25
Distribution
Part of a larger recall action
This product is one of 2 recalled by GE Medical Systems, LLC 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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