Reported Dec 26, 2018 · Terminated
IMRIS ORT 100 table, Part Numbers: (a) 110470-000, (b) 110470-600 - Product Usage: The ORT200 and ORT300 are intended…
Deerfield Imaging, 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: Deerfield Imaging, Inc. · 5101 Shady Oak Rd S · Minnetonka, MN · 55343-4100
Is this the product you have?
- IMRIS ORT 100 table
- Part Numbers
(a) 110470-000(b) 110470-600 -
- Product UsageThe ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables are indicated for imagining from head to sacrum with MR/CT imaging modalities. The ORT100 table is intended for use during diagnostic examination or surgical procedures to support and position the patient
- Lot codes and dates
- (a) 110470-000
- Serial Numbers
1000284510002341100036291000380110003830100028471000279610003243100026541000384110002607100073481000742410005651100042501000443910003241100068861000284810006438100030071000457610003245 (b) 110470-600
- Serial Numbers
10003244100030641000324410002343
- Amount recalled
- 27 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
- Nationwide
Why it was recalled
Table may drift in the roll position while in use
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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