Reported Nov 14, 2012 · Terminated
0.7U163CS-36 In combination with below systems MUX-100H, MUX-100D, MobileArt Evolution Brand Name: MUX-100H.…
Shimadzu Medical Systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Shimadzu Medical Systems · 20101 S Vermont Ave · Torrance, CA · 90502-1328
Is this the product you have?
- 0.7U163CS-36 In combination with below systems MUX-100H, MUX-100D
- MobileArt Evolution Brand NameMUX-100H
- Classification NameMobile x-ray system. Device Model#MUX-100H
- Product UsageThe device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency
- Lot codes and dates
- S/N of X-ray tube
139 of 139 codes
630496304863074630816308263077633506334963629636476390962729642146603366032700707006570364663276633170058663257095571241709207184872472724627305673058733417367574577745637456574557745587484674845754557545275457757287573775736760597605776060760547606276360763667661276636763367691676655766477693876940
- S/N of X-ray tube
- Amount recalled
- 288 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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