FDA Medical Device Recalls (openFDA)
GE Healthcare, LLC: NM/CT 870 CZT Model # H3906CW
- Recall number
- Z-2993-2020
- Recalling firm
- GE Healthcare, LLC
- Product
- NM/CT 870 CZT Model # H3906CW
- 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
- 15 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 # 87CX63007 System ID: AH0101NM05 Serial # 87CX63008 System ID: 190020NU01 Serial # 87CX63006 System ID: 030240NU11 Serial # 87CX63015 System ID: 705743NM870 Serial # 87CX63014 System ID: 030078NU28 Serial # 87CX63011 System ID: M4184879 Serial # 87CX63003 System ID: M9886873 Serial # 87CX63004 System ID: X171582003 Serial # 87CX63009 System ID: M171582018 Serial # 87CX63010 System ID: UC1796NU01 Serial # 87CX63013 System ID: NO1068MN18 Serial # 87CX63005 System ID: A004NU20 Serial # 87CX63002 System ID: C028NU01 Serial # 87CX63012 System ID: C028NU02 Serial # 87CX63001 System ID: 900010NU12
- 510(k) numbers
- ["K153402"]
- 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