RapidScreen RS-Digital, Medical Image Analyzer.
FDA device recall Z-1174-06 · posted 2006-06-27 · Terminated
Recall details
- Recalling firm
- Riverain Medical Group
- Reason for recall
- The device has an actual sensitivity of 58.2% and a specificity of 3.9% (false positives per image). The product is approved to have a sensitivity of 63.3% and a specificity of 5.0. Thus, there is a difference of -5.1% in sensitivity and +1.1 in specificity.
- Action taken
- The recalling firm sent a letter dated 5/4/06 to medical facilities, sent a letter dated 5/5/06 to distributors, and sent a letter dated 5/10/06 to GE Healthcare, Waukesha, WI.
- Root cause
- Other
- Status
- Terminated
- Product code
- MYN
- Quantity affected
- 72 devices
- Distribution
- Nationwide. The product was distributed to consignees located in IL, CA, MO, CO, WA, MT, ID, OR, NC, TX, TN, FL, UT, MN, OK, WI, OH, AZ, IA, and PA.
- Date initiated
- 2006-05-04
- Date posted
- 2006-06-27
- Date terminated
- 2013-02-20
- Location
- Miamisburg, OH
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