FDA Medical Device Recalls (openFDA)
Riverain Medical Group: RapidScreen RS-2000D, Medical Image Analyzer.
- Recall number
- Z-1173-06
- Recalling firm
- Riverain Medical Group
- Product
- RapidScreen RS-2000D, Medical Image Analyzer.
- Status
- Terminated
- Initiated
- 2006-05-04
- Posted
- 2006-06-27
- Terminated
- 2013-02-20
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- P000041/S1
- Product code
- MYN
- Firm FEI
- 3005156333
- Firm city
- Miamisburg
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28