0.7/1.3U163CS-36 In combination with below systems recall
0.7/1.3U163CS-36 In combination with below systems MobileArt Evolution, MobileDaRt Evolution Product Usage: The device is a mobile X-ray system in…
Why was 0.7/1.3U163CS-36 In combination with below systems recalled?
Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m) Beam quality --(1) Half-value layer (HVL), which was revised in 2006. Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006.
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?
S/N of X-ray tube: 64510 66036 66026 66027 71866 70641 72470 72740 72735 73360 73365 2XY0084531 73372 73679 73671 73966 74248 74258 74546 74548 74291 74556 74832 74834 74833 74829 74837 76058 76326 76069 76355 76364 76361 76356 76358 76363 76367 2XY0080666 80666 2XY0080650 2XY0080345 2XY0080649 2XY0080656 2XY0082453 2XY0082456 2XY0082461 2XY0082748 2XY0083039 2XY0075448 2XY0082750 2XY0083070 2XY0082778 2XY0083047 2XY0083058 2XY0083680 2XY0083627 2XY0083633 2XY0083951 2XY0084556
- Product
- 0.7/1.3U163CS-36 In combination with below systems MobileArt Evolution, MobileDaRt Evolution Product Usage: The device is a mobile X-ray system in…
- Recalling firm
- Shimadzu Medical Systems
- Quantity
- 133 units
- Distribution
- US Nationwide Distribution
- Recall date
- November 14, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)