FDA Medical Device Recalls (openFDA)
GE Healthcare, LLC: Discovery 670 DR (Model H3100BT), NM/CT 870 DR (Model 3100Q and H3100AS), Discovery NM670 Pro (Model 3100XB), Discovery 670 ES (Model H3100XF) - Product Usage: intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality.
- Recall number
- Z-0857-2021
- Recalling firm
- GE Healthcare, LLC
- Product
- Discovery 670 DR (Model H3100BT), NM/CT 870 DR (Model 3100Q and H3100AS), Discovery NM670 Pro (Model 3100XB), Discovery 670 ES (Model H3100XF) - Product Usage: intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality.
- Status
- Open, Classified
- Initiated
- 2020-12-10
- Posted
- not on file
- Terminated
- not on file
- Reason
- GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.
- Root cause
- Process control
- Action
- The firm initiated their action by letter to the consignees on 12/10/2020. The letter explained the issue and stated that GE would inspect, and if required, correct the affected units. Questions and concerns may be directed to GE Healthcare Service at 1-800-437-1171 or the consignee's local Service Representative.
- Quantity
- 52 untits
- Distribution
- Worldwide
- Lot, serial or model codes
- Discovery 670 DR (Model H3100BT), Serial Numbers: DRGY56033, DRGY56037, DRGY56035, DRGY56030, DRGZ56043, DRGZ56042, DRGY56032, DRGY56031, DRGY56034, DRGY56036 NM/CT 870 DR (Model 3100Q), Serial Numbers: 870Y64066, and (Model H3100AS), Serial Numbers: 870Y64077, 870Y64064, 870Y64081, 870Y64079, 870Y64067, 870Y64074, 870Z64117, 870Y64078, 870Y64080, 870Y64069, 870Y64085, 870Z64121, 870Z64119, 870Z64122, 870Y64056, 870Y64063, 870Z64114, 870Z64115, 870Y64068, 870Y64082, 870Z64116, 870Z64120, 870Y64065, 870Y64084, 870Y64061, 870Y64083, 870Z64113, 870Y64070, 870Z64123, 870Y64058, 870Z64118, 870Y64057 Discovery NM670 Pro (Model 3100XB), Serial Numbers: PRGY52027, PRGY52031, PRGZ52047, PRGZ52046, PRGY52028, PRGZ52048, PRGY52029, PRGY52030 Discovery 670 ES (Model H3100XF), Serial Numbers: ESGZ53005
- 510(k) numbers
- ["K093514"]
- PMA numbers
- not on file
- Product code
- KPS
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- 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