0.7U163CS-36 In combination with below systems MUX-100H, MUX-100D, MobileArt Evolution Brand Name: MUX-100H. Classificat
FDA device recall Z-0262-2013 · posted 2012-11-08 · Terminated
Recall details
- Recalling firm
- Shimadzu Medical Systems
- Reason for recall
- 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.
- Action taken
- Shimadzu sent an Urgent Voluntary Medical Device Recall - Field Safety Notice letters dated September 19, 2012 to all the affected customers. The letter identifed the description of non-compliance, how to identify the affected products, corrective action plan by Shimadzu and actions to be taken customers. Customers were instructed to contact their local Shimadzu representative or contact Shimadzu National Technical Support at Shimadzu Medical Systems National Technical Support (800) 228-1429.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- IZL
- Quantity affected
- 288 units
- Distribution
- US Nationwide Distribution
- Date initiated
- 2011-10-28
- Date posted
- 2012-11-08
- Date terminated
- 2016-07-26
- Location
- Torrance, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SHIMADZU MOBILE X-RAY SYSTEM MUX-100 SERIES (K001517) | Shimadzu Corp. | 2000-06-27 |