Philips Healthcare MobileDiagnostwDR system. Mobile recall
Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ray System Product Usage: MobileDiagnost wDR is a mobile digital radiography…
Why was Philips Healthcare MobileDiagnostwDR system. Mobile recalled?
The Instructions for Use (IFU) for the MobileDiagnost wDR fails to comply with a Federal standard. The IFU does not provide tolerance levels for several generator values as required by 1020.30(h)(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?
System Code - 712001
- Product
- Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ray System Product Usage: MobileDiagnost wDR is a mobile digital radiography…
- Recalling firm
- Philips Healthcare Inc.
- Quantity
- 240 systems US -- 1 system within Puerto Rico
- Distribution
- US Nationwide Distribution including Puerto Rico
- Recall date
- August 28, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)