Reported Jan 17, 2018 · Terminated
Mobile Mini C-arm system Part # 1000-0001. 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 # 1000-0001. 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 ListModel #
229 of 229 codes
1000-00015A2175D5285D5665D6085D6475D6825C4075D5295D5675D6095D6485D6835C4175D5305D5685D6105D6495D6845C4235D5315D5695D6115D6505D6855C4275D5325D5705D6125D6515D6865C4285D5335D5715D6135D6525D6875D5015D5345D5725D6145D6535D6905D5035D5355D5735D6155D6545D6945D5045D5365D5745D6165D6555D6955D5055D5375D5755D6205D656
- Serial Number ListModel #
- 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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