GE Medical Systems Recalls Discovery IGS 730 X-ray Systems
GE Medical Systems is recalling 102 Discovery IGS 730 Interventional Fluoroscopic X-ray Systems due to potential X-ray abort errors that may cause loss of imaging mode.
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 is classified as FDA Class II and 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, SCS is recalling 102 Discovery IGS 730 Interventional Fluoroscopic X-ray Systems. The recall covers specific model and serial numbers distributed across multiple U.S. states and international locations.
The recall is issued because the systems may experience X-ray abort errors. These errors could result in the loss of imaging mode before or during fluoroscopic use. The source text does not report any specific injuries or illnesses associated with this defect.
Healthcare facilities and users of these devices should contact GE Medical Systems for further instructions on how to address the issue. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Discovery IGS 730 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 (9)
- Model Number 5730890
- Serial Numbers (System ID): 00000D3-17-030 (904BHHCHY)
- 00000D3-17-032 (083172440628)
- 661327IGS730 (00000D3-18-001)
- GON4598369 (00000D3-18-004)
- 082416140028 (00000D3-17-025)
- M4234253 (00000D3-17-028)
- YV3601 (00000D3-18-005)
- 6073XR0058 (00000D3-17-031).
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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