Reported Apr 5, 2017 · Terminated
iConnect Enterprise Archive software.
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?
- iConnect Enterprise Archive software.
- Lot codes and dates
77 of 77 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 CCS5.35.5.18.308.30.28.40.08.40.1 HF05578.40.28.40.2.18.40.2.28.70 - Now Obsolete
- Amount recalled
- 371 sites potentially have the affected software
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
The versions allow images to be stored without pixel data, resulting in the system not being able to present all the prior studies, which could cause a delay in treatment in determining the progression of disease.
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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