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INNOVA recallZ-1778-2024 · GE Medical Systems, SCS · initiated Mar 18, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from GE Medical Systems, SCS or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number
Z-1778-2024
Status
Open, Classified
Initiated by the company
Mar 18, 2024
Posted by the FDA
May 6, 2024
Recalling firm
GE Medical Systems, SCS
Quantity
3 units
Product code
OWB
FDA submissions
K181403
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 description

GE Healthcare Innova IGS 6, Interventional fluoroscopic x-ray systems

Code information (models, lots, serial numbers)

UDI/DI 00840682124614, Serial Numbers: B3-23-015, B3-23-016, B3-24-002;

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

3 devices cleared under K181403 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 94305).

Sources and updates

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