Z-1173-06

RapidScreen RS-2000D, Medical Image Analyzer

Name: Z-1173-06 RapidScreen RS-2000D, Medical Image Analyzer
Creator: Riverain Medical Group
Published: 2006-05-04
License: https://open.fda.gov/license/

Riverain Technologies / initiated 2006-05-04 / Terminated

FDA source

Riverain Medical Group began a recall of RapidScreen RS-2000D, Medical Image Analyzer on 2006-05-04. The reason FDA records is "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%...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1173-06
Status: Terminated
Initiated: 2006-05-04
Posted: 2006-06-27
Terminated: 2013-02-20
Recalling firm: Riverain Technologies
Product: RapidScreen RS-2000D, Medical Image Analyzer.
Product code: MYN Analyzer, Medical Image
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.
FDA 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 in commerce: 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.
Product codes and lots: Serial numbers: 39CKM51, 1BCKM51, 25-1034, 4BCKM51, F9CDM51, 25-1011, 25-1012, 25-1013, 25-1015, 25-1017, 25-1021, 25-1025, 25-1028, 25-1029, 25-1023, 25-1024, 25-1027, 25-1033, 25-1030, 25-1031, 25-1035, 25-1036, 25-1032, 25-1037, 25-1038, 25-1039, 25-1041, 25-1042.

Product code MYN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)