GE Healthcare Recalls Innova IGS 530 Angiographic X-ray Systems
GE Healthcare is recalling 17 Innova IGS 530 angiographic X-ray systems due to a potential loss of C-arm gantry motion capability.
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 the loss of motion capability could compromise patient safety, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
GE Healthcare is recalling 17 units of the Innova IGS 530 angiographic X-ray system. These devices are used to generate fluoroscopic and rotational images of human anatomy for diagnostic, interventional, and image-guided surgical procedures.
The recall is being issued because GE Healthcare has become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on these fluoroscopic interventional imaging systems. The affected units were distributed worldwide, including in the United States and various international markets.
Healthcare facilities and users should contact GE Healthcare for further instructions regarding the recall and potential remediation of the affected devices.
The recalled product
- Product
- GE Healthcare Innova IGS 530. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
- Manufacturer
- GE Healthcare
- Hazard
- Affected units
- 17
Distribution
Part of a larger recall action
This product is one of 13 recalled by GE Healthcare 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.
See all 13 products in this recall →Related recalls
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