GE Medical Systems Recalls Discovery IGS 740 X-ray Systems
GE Medical Systems is recalling 102 Discovery IGS 740 systems because X-ray abort errors may cause loss of imaging mode during fluoroscopic 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text does not report any injuries or illnesses, and the hazard is a functional defect (loss of imaging) rather than a direct physical injury mechanism, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
GE Medical Systems, SCS is recalling 102 Discovery IGS 740 Interventional Fluoroscopic X-ray Systems. The recall covers specific model numbers 5730891 and 5759342 with designated lot numbers. These devices are distributed in 19 U.S. states and 25 international countries.
The recall is issued because the systems may experience X-ray abort errors. This defect could result in the loss of imaging mode before or during fluoroscopic use. The source text does not report any injuries, illnesses, or deaths associated with this defect.
Healthcare facilities and users should contact GE Medical Systems for instructions on how to address the issue. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Discovery IGS 740 Interventional Fluoroscopic X-ray Systems
- Manufacturer
- GE Medical Systems, SCS
- Affected units
- 102
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 (7)
- Model Number 5730891- Lot Number (System ID): 00000D4-17-029 (478765NSP)
- 00000D4-17-031 (712279DIS)
- 00000D4-17-030 (716845DISC)
- 00000D4-18-003 (951TVHDISC740)
- 00000D4-18-001 (352751DISC)
- 00000D4-17-032 (SA1011VA02)
- Model Number 5759342 - 00000D4-17-028 (GON 4610398).
Distribution
Part of a larger recall action
This product is one of 3 recalled by GE Medical Systems, SCS 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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