IMPAX CV Pediatric Echo Reporting recall: Software Issue
IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation of digital…
Why was IMPAX CV Pediatric Echo Reporting recalled?
Failure to effectively install and test a hotfix to correct the known software defect within the IMPAX CV 7.8 SU3-OCR Service.
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?
Model L9M21000 - Software versions: IMPAX CV 7.8 SU3/SU4 - OCR Service
- Product
- IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation of digital…
- Recalling firm
- AGFA Corp.
- Quantity
- One
- Distribution
- Distribution to SC only
- Recall date
- June 4, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)