Recall record at a glance
| Official record | Z-0794-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Merge Healthcare, Inc. |
| Report date | Feb 17, 2016 |
| Recall initiation date | Dec 17, 2015 |
| Quantity | 164 |
| Location | Hartland, WI, United States |
Official product description
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.
Why the product was recalled
Potential incorrect Standardized Uptake Values (SUV) measurements in RadSuite.
Distribution information
Nationwide Distribution to the states of : MN, WI, IL, PA, AL, MO, MT, AZ, CA, OH, FL, SC, MI, TN, CO, NV, IN, NY, MD, AR, KS, NY, IN, IA, TX, OK, NC, WA and DC.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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