Philips Healthcare DuraDiagnost stationary X-ray system recall
Philips Healthcare DuraDiagnost stationary X-ray system
Why was Philips Healthcare DuraDiagnost stationary X-ray system recalled?
The detector may signal that it is ready for acquisition when it actually is not, resulting in failure to properly acquire the X-ray image.
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?
software version - 4.0.2, 4.0.3, 4.0.4 into 4.0.5
- Product
- Philips Healthcare DuraDiagnost stationary X-ray system
- Recalling firm
- Philips Healthcare
- Quantity
- 5
- Distribution
- USA (nationwide) Distribution to the states of : ( DuraDiagnost) to the states of : OH, CA, WA and NE. (DigitalDiagnost) to the states of : AK, AZ, AL, CA, CT, CO, DE, FL, GA, HI, ID, KY, LA, MA, MN, MD, MS, ME, MO, NE, NY, ND, OH and PA.
- Recall date
- June 15, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)