GE Healthcare Discovery IGS 730 Recalled for Potential Image Loss
GE Medical Systems is recalling 54 Discovery IGS 730 systems due to a risk of 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 risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
GE Medical Systems, LLC is recalling 54 units of the Discovery IGS 730 system. These devices are indicated for use in generating fluoroscopic and rotational images of human anatomy. The recall covers systems distributed nationwide in the United States and in various countries worldwide, including Canada, the United Kingdom, and Germany.
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 malfunction can result in a potential non-recoverable loss of image acquisition. The source text does not report any specific injuries or illnesses associated with this defect.
Healthcare facilities should contact GE Medical Systems for further instructions regarding the recall. The specific serial numbers and system IDs for the affected units are listed in the official recall documentation.
The recalled product
- Product
- GE Healthcare, Discovery IGS 730. Indicated for use in generating fluoroscopic and rotational images of human anatomy.
- Manufacturer
- GE Medical Systems, LLC
- Affected units
- 54
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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