Reported Jan 17, 2018 · Terminated
Mobile Mini C-arm system Part # 1000-0004. Intended to provide the physician with general fluoroscopic visualization of…
Orthoscan, Inc.
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: Orthoscan, Inc. · 8212 E Evans Rd · Scottsdale, AZ · 85260-3670
Is this the product you have?
- Mobile Mini C-arm system Part # 1000-0004. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures.
- Lot codes and dates
- Serial Number List
498 of 498 codes
5E12905H01785H01255E8335E11645F03955E7305E1055H01265E9215E7425F04005E7565E09405H01305F01265F02825F04125E7635E09435H01515F02295H02735F04415E8415E09615H01725F02305E09445F04495F02325E09815H01905F03875E09455F04515H02915E09825H03335F04455E09555F04565F01775E10095E09545F04535E10005F04685F02425E10425E10435F04575E10255F04715F02955E10515E12345F04655E11775F0482
- Serial Number List
- Amount recalled
- 2012 total
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
OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices. Specifically, the system software allows a user to activate the Digital Zoom feature in the course of taking a live image exposing a larger x-ray field than can be viewed by the user
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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