Reported Feb 17, 2016 · Terminated
RadSuite, a picture archive and communications system. Model Numbers Versions 5.30.0, 5.30.1, 5.30.2, 5.30.2 SB0344,…
Merge Healthcare, 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: Merge Healthcare, Inc. · 900 Walnut Ridge Dr · Hartland, WI · 53029-8347
Is this the product you have?
- RadSuite, a picture archive and communications system. Model Numbers Versions 5.30.0, 5.30.1, 5.30.2, 5.30.2 SB0344, 5.30.3, 5.30.4, 5.30.4 HF0418E, 5.30.5, 5.30.5 HF0404E, 5.30.5 HF0413E, 5.30.5 HF390E, 5.30.5 SB0368, 5.30.6, 5.30.6 HF0405E, 5.30.6 HF0406E, 5.30.7, 5.30.7 HF0429E, 5.30.7 HF0441E, 5.30.7 HF0446E, 5.30.7 HF0470E, 5.30.7 HF0473E, 5.30.8, 5.30.8 HF0477E, 5.30.8 HF0490E, 5.30.8 HF0495 SB0508E, 5.30.8 HF0495E, 5.30.8 HF0495E SB504E, 5.30.8 HF0550, 5.30.8 SB0485E, 5.30.8 SB0486E, 5.30.X SB0381E, 5.35.1, 5.35.1 HF0487E, 5.35.1 HF0489E, 5.35.2, 5.35.3, 5.35.4, 5.35.4 HF0513, 5.35.4 HF0518, 5.35.4 HF0528, 5.35.4 HF0531, 5.35.4 HF0535, 5.35.4 HF0546, 5.35.4 HF0555, 5.35.4 HF0555.1, 5.35.4 HF0555.2, 5.35.4 HF0555.3, 5.35.4 HF0560, 5.35.4 Powerscribe Validation, 5.35.5, 5.35.5 From CCS, 5.35.5.1, 8.30.0, 8.30.1, 8.30.3, 8.30.3.1, 8.30.4, 8.30.5, 8.30.6, 8.30.6.1, 8.30.6.2, 8.30.6.3, 8.30.7, 8.30.7.1, 8.30.7.2, 8.30.7.3, 8.30.7.3-Hopkins, 8.30.7.4, 8.30.7.5, 8.30.7.5.b, 8.30.7.6, 8.30.7.7, 8.30.7.8.
- Lot codes and dates
73 of 73 codes
Versions 5.30.05.30.15.30.25.30.2 SB03445.30.35.30.45.30.4 HF0418E5.30.55.30.5 HF0404E5.30.5 HF0413E5.30.5 HF390E5.30.5 SB03685.30.65.30.6 HF0405E5.30.6 HF0406E5.30.75.30.7 HF0429E5.30.7 HF0441E5.30.7 HF0446E5.30.7 HF0470E5.30.7 HF0473E5.30.85.30.8 HF0477E5.30.8 HF0490E5.30.8 HF0495 SB0508E5.30.8 HF0495E5.30.8 HF0495E SB504E5.30.8 HF05505.30.8 SB0485E5.30.8 SB0486E5.30.X SB0381E5.35.15.35.1 HF0487E5.35.1 HF0489E5.35.25.35.35.35.45.35.4 HF05135.35.4 HF05185.35.4 HF05285.35.4 HF05315.35.4 HF05355.35.4 HF05465.35.4 HF05555.35.4 HF0555.15.35.4 HF0555.25.35.4 HF0555.35.35.4 HF05605.35.4 Powerscribe Validation5.35.55.35.5 From CCS5.35.5.18.30.08.30.18.30.38.30.3.18.30.48.30.58.30.68.30.6.1
- Amount recalled
- 164
Where it was sold
Why it was recalled
Potential incorrect Standardized Uptake Values (SUV) measurements in RadSuite.
This product could cause temporary or reversible health problems — stop using it.
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