GE Healthcare recall: Software Issue
GE Healthcare, Xeleris 2 Processing & Review Workstation. The display, processing, archiving, and communication of data acquired by Emission…
Why was GE Healthcare recalled?
GE Healthcare has become aware of a software issue in your Xeleris 2.1 workstation (that is used for processing Discovery 530/570 data), that may impact patient safety. On imported CT scans, Myocardial Perfusion Imaging (MPI) studies may create artifacts in attenuation corrected images. This may lead to a potential for misdiagnosis.
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?
Mfg Lot or Serial # 0000CZC7105FJM000 00000CZC827NRN000 00000CZC8283V4000 0000CZC8283V47000 0000CZC8283V72001 0000CZC8283TX5001 00000000211423001 0000CZC8161XJT000 0000CZC94154WV003 0000CZC83942HL000 0000CZC8396CC9001
- Product
- GE Healthcare, Xeleris 2 Processing & Review Workstation. The display, processing, archiving, and communication of data acquired by Emission…
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 11
- Distribution
- Worldwide Distribution - USA including GA, and NY; and countries of: Canada, Israel, Italy and Switzerland.
- Recall date
- May 1, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)