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Terminated

RapidScreen RS-Digital, Medical Image Analyzer.

FDA Recall Z-1174-06 · Posted 2006-06-27

Recalling FirmRiverain Medical Group
Recall StatusTerminated
Product CodeMYN
Date Initiated2006-05-04
Date Terminated2013-02-20
Product Quantity72 devices

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.

Firm 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.

Root Cause

Other

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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