FDA Medical Device Recalls (openFDA)
Riverain Medical Group: RapidScreen RS-Digital, Medical Image Analyzer.
- Recall number
- Z-1174-06
- Recalling firm
- Riverain Medical Group
- Product
- RapidScreen RS-Digital, 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
- 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.
- Lot, serial or model codes
- Serial numbers: 58HVH31, F8HVH31,49HVH31, 87HVH31, 47HVH31, F7HVH31, H7HVH31, 2RCTH31, 1RCTH31, B8HVH31, GQCTH31, G031M31, C031M31, 3131M31, 8031M31, 1131M31, 2FNNS31, BDNNS31,GDNNS31, FDNNS31, JDNNS31, GFNNS31, 2433X31, D333X31, F433X31, 5L3R241, 7L3R241, 148HN41, 648HN41, 348HN41, 848HN41, 838HN41, BR5VQ41, 4R5VQ41, JL0VQ41, JL0VQ41, 3N0VQ41, 2P0VQ41, BPZTQ41, FL0VQ41, 946VQ41, 296VQ41, 9M0VQ41, CL0VQ41, H86VQ41, 1QCWQ41, 1LCWQ41, 5LCWQ41, JNCWQ41, 596VQ41, 4NCWQ41, 9LCWQ41, GM0VQ41, BNCWQ41, 8QCWQ41, DN0VQ41, F26VQ41, B86VQ41, G96VQ41, 996VQ41, JR5VQ41, 2BCKM51, F9CKM51,79CKM51, H9CKM51, 39CKM51, C9CKM51, 1BCKM51, 59CKM51, 4BCKM51, 20-168, 20-160, and 7S5VQ41.
- 510(k) numbers
- not on file
- PMA numbers
- ["P000041/S2"]
- 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