Z-1783-2024Class II
GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
GE Medical Systems SCS / initiated 2024-03-18 / Open, Classified / root cause: manufacturing process
GE Medical Systems, SCS began a recall of GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems on . FDA classified it as Class II and gives the reason as "GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1783-2024
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- GE Medical Systems SCS
- Product
- GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
- Product code
- OWB Interventional Fluoroscopic X-Ray System
- Reason for recall
- GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.
- Root cause tag
- manufacturing process
- FDA root cause
- Process control
- Action
- GE Healthcare issued an UGENT MEDICAL DEVICE CORRECTION notice to its consignees on 03/18/2024 via letter. The notice explained the issue, hazard, and requested the following actions be taken: Every day prior to first use of the device, perform a functional check of the gantry movements and images of your device to look for the following behaviors: 1. Abnormal noise during gantry movement. 2. Image misalignment. If any of the above is observed, DO NOT use the device and call GE HealthCare Service Immediately. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Post this letter in a visible location beside the product. GE HealthCare will schedule a service appointment to correct this potential issue in a timely manner. For questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
- Quantity in commerce
- 1 unit
- Distribution
- Worldwide distribution - US Nationwide in the states of CA, FL, GA, IN, MA, NC, OK, SC, TN, TX, VA and the countries of Armenia, China, France, Hungary, India, Italy, Japan, Kazakhstan, Lithuania, Mexico, Russia, Spain, Taiwan, Turkey, Vietnam
- Product codes and lots
- UDI/DI 00195278719263, Serial Numbers: M3-23-117
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1777-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1778-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1779-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1780-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1781-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1782-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1783-2024 | Class II | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.