Philips DuraDiagnost stationary X-ray system recall
Philips DuraDiagnost stationary X-ray system
Why was Philips DuraDiagnost stationary X-ray system recalled?
Buttons or keys on the monitor allow the user to turn the volume setting down to 0", in which case the beep will not be heard at the conclusion of an exposure, as required 21 CFR 1020.31(j), and the Height-Adjustable Tabletop is missing the required labels [21 CFR 1010.2., 21 CFR 1010.3(a), and 21 CFR 1020.30(3)].
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?
SN: 140054 140059 150013 150014 150039 150041 150042 150052 150053 150055 150056 150059 150061 150091 150093
- Product
- Philips DuraDiagnost stationary X-ray system
- Recalling firm
- Philips Electronics North America Corporation
- Quantity
- 15
- Distribution
- US Distribution to the states of : ME, NE, OR, CA, TX, NC, WA and OH.
- Recall date
- September 7, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)