FDA Medical Device Recalls (openFDA)
GE Healthcare, LLC: NM/CT 860, SPECT/CT
- Recall number
- Z-2992-2020
- Recalling firm
- GE Healthcare, LLC
- Product
- NM/CT 860, SPECT/CT
- Status
- Terminated
- Initiated
- 2020-08-14
- Posted
- not on file
- Terminated
- 2021-05-06
- Reason
- Rotor bearing screws were found loose on detector.
- Root cause
- Use error
- Action
- GE Healthcare issued an Urgent Medical device correction notification on August 14, 2020. It states the following: 1. GE Healthcare will inspect and, if required, correct all affected products at no cost to you. 2. A GE Healthcare representative will contact you to arrange for the correction 3. Please complete the acknowledgement form and return it to GE Healthcare promptly upon receipt and no later than 30 days from receipt to nm.fmi40890.responses@ge.com If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
- Quantity
- 4 units
- Distribution
- USA : AR CT FL GA IL KS KY LA MA MD MI MN MO NE NJ NV NY OH OK RI SC TN TX VA VT WA WI OUS: ARGENTINA AUSTRIA BELGIUM BRAZIL Canada CHINA FRANCE GERMANY GREECE INDIA ISRAEL ITALY JAPAN Korea (Republic of) NETHERLANDS NORWAY PANAMA POLAND PORTUGAL Russia SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND TURKEY UNITED KINGDOM VIETNAM
- Lot, serial or model codes
- Serial # 850X61003 , System ID: 401793860NM, Model # H3908AD Serial # 860X62001 , System ID:E6843969, Model # H3908AE Serial # 870X64005 , System ID:HC4387NU05, Model # H3100AS Serial # 860X62002 , System ID:PL0399NM01, Model # H3100AS
- 510(k) numbers
- ["K173816"]
- 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