GE Healthcare Allia IGS 7 X-ray Systems Adhesive Bolt Failure Recall
GE Healthcare is recalling Allia IGS 7 interventional x-ray systems due to potential adhesive failure on bolts securing the detector and x-ray tube, which could fall 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: FDA Class II medical device recall involving a structural defect that could cause equipment to fall during use, posing potential serious injury. No incidents have been reported to date, keeping the severity at High rather than Severe.
Plain-English summary
GE Healthcare is recalling Allia IGS 7 interventional fluoroscopic x-ray systems due to a potential manufacturing defect involving adhesive application on critical bolts. Adhesive material may not have been properly applied to certain bolts in the frontal gantry assembly of affected units.
If adhesive is inadequate or missing, bolts could loosen and potentially cause the detector/elevator or x-ray tube to fall during operation. This could result in equipment damage and injury to patients and clinical staff.
Six units with this defect have been identified and distributed worldwide, including across the United States and internationally. Affected serial numbers are: D4-23-035, D4-23-036, D4-23-038, D4-23-042, D4-24-001, and D4-24-003.
Healthcare facilities operating these systems should immediately contact GE Healthcare to verify whether their unit is affected and follow manufacturer guidance for inspection and corrective measures.
The recalled product
- Product
- GE Healthcare Allia IGS 7, Interventional fluoroscopic x-ray systems
- Manufacturer
- GE Medical Systems, SCS
- Affected units
- 6
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)
- UDI/DI 00195278215543
- Serial Numbers: D4-23-035
- D4-23-036
- D4-23-038
- D4-23-042
- D4-24-001
- D4-24-003
Distribution
Part of a larger recall action
This product is one of 7 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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