Elscint APEX Helix recall
Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Product Usage: The intended use of the Quasar system is to perform…
Why was Elscint APEX Helix recalled?
Potential safety issue related to unintended radial detector motion, which may occur during patient setup or at the end of a patient scan. This failure mode has been observed on a single system, in which the detector moved to the home position and then slowly starting drifting inward toward the patient. This generated both a visual and audio alert condition on both the console and the gantry. N
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
all serial numbers are listed in Product 1.
- Product
- Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Product Usage: The intended use of the Quasar system is to perform…
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 3062 units (1182 US, 1880 OUS)
- Distribution
- Worldwide Distribution-USA (nationwide) including Puerto Rico and Guam and the countries of Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea (Republic of), Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Malta, Martinique, Mexico, Morocco, Namibia, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, and United Kingdom.
- Recall date
- March 19, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)