Recall Z-1173-06 ยท MYN Analyzer, Medical Image
Riverain Medical Group
RapidScreen RS-2000D, Medical Image Analyzer.
| Date | Jun 27, 2006 (initiated May 4, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 29 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.