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U.S. Department of Health and Human Services

Class 2 Device Recall Allia IGS 7 Pulse

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 Class 2 Device Recall Allia IGS 7 Pulsesee related information
Date Initiated by FirmApril 20, 2026
Date PostedJune 05, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2316-2026
Recall Event ID 98880
510(K)NumberK232344 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductAllia IGS 7 Pulse angiographic X-ray system
Code Information UDI-DI: 00195278719720; Serial Numbers: D3-23-024, D3-23-029, D3-24-001, D3-24-002, D3-24-005, D3-24-006, D3-24-008, D3-24-009, D3-24-010, D3-24-013, D3-24-014, D3-24-016, D3-24-019, D3-24-020, D3-24-021, D3-24-023, D3-24-025, D3-25-001, D3-25-002, D3-25-003, D3-25-005, D3-25-006, D3-25-007, D3-25-008, D3-25-009, D3-25-010, D3-25-013, D3-25-016, D3-25-017, D3-25-018, D3-25-026, D3-25-027, D3-25-029, D3-25-030, D3-25-034, D3-25-036, D3-25-037, D3-26-001, D3-26-002, D3-26-007
FEI Number 2126677
Recalling Firm/
Manufacturer		 GE Medical Systems, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information ContactGE HealthCare Service
800-437-1171
Manufacturer Reason
for Recall		GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
FDA Determined
Cause 2		Device Design
ActionAn URGENT MEDICAL DEVICE CORRECTION dated 4/20/26 was sent to customers. Actions to be taken by Customer/User You can continue to use your system. As a reminder, qualified service personnel must follow the Service Manual applicable to your system and use the appropriate personal protective equipment (PPE) for electrical hazards when performing any activity inside the cabinet while power is ON. If any abnormal condition is observed on the Iris Power Cable during servicing, such as loose or visibly exposed wires, qualified service personnel must follow the Electrical Lockout/Tagout Procedure as described in Service Manual. Please ensure that all potential users and service personnel in your facility are made aware of this safety notification and the recommended actions and post this letter in a visible location near the C-FRT cabinet. Please retain this document for your records. Please complete and return the attached acknowledgement form electronically via FMI 18014 Digital Response Form or print, fill out manually, scan, and email to recall.18014@gehealthcare.com.
Quantity in Commerce35 units
DistributionWorldwide - US Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OWB
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