Reported Dec 16, 2020 · Ongoing
MH-200S, system with Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography,…
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?
- MH-200S, system with Ceiling
- Suspended C-arm Support - Product Usageintended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures
- Lot codes and dates
- Affected Serial Numbers
0161K359010161K469010161K582020161K560010161K557020161K553010161K552020161K471020161K468020161K463010161K365010161K363010161K357020161K3620240AAE701B0010161K493010161K486010161K485010161K364020161K356020161K352020161K56502
- Affected Serial Numbers
- Amount recalled
- 22 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the operator has released the movement lever. This could result in possible collision or harm to the patient or system operator.
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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