Z-1129-2021Class II

System, X-Ray, Tomography, Computed: Revolution Apex, Revolution CT with Apex Edition

Name: Z-1129-2021 System, X-Ray, Tomography, Computed: Revolution Apex, Revolution CT with Apex Edition
Creator: GE Healthcare, LLC
Published: 2020-12-17
License: https://open.fda.gov/license/

GE Healthcare / initiated 2020-12-17 / Terminated

FDA source

GE Healthcare, LLC began a recall of System, X-Ray, Tomography, Computed: Revolution Apex, Revolution CT with Apex Edition on 2020-12-17. FDA classified it as Class II and gives the reason as "GE Healthcare has become aware of a potential issue on Revolution Apex, Revolution CT with Apex Edition, Revolution CT, and Revolution CT ES systems where the table pinch protector could be damaged or missing leading to...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1129-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-17
Posted: 2021-02-17
Terminated: 2023-01-09
Recalling firm: GE Healthcare
Product: System, X-Ray, Tomography, Computed: Revolution Apex, Revolution CT with Apex Edition
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: GE Healthcare has become aware of a potential issue on Revolution Apex, Revolution CT with Apex Edition, Revolution CT, and Revolution CT ES systems where the table pinch protector could be damaged or missing leading to exposed table screws which could cause a laceration due to a sharp edge.
FDA root cause: Process change control
Action: The manufacturer sent an "Urgent Medical Device Correction" letter (GEHC Ref# 25496) to customers with affected systems on 12/17/2020.
Quantity in commerce: 96 units
Distribution: Worldwide - US Nationwide Distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NJ, NV, NY, NH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV; In the countries of Algeria, Australia, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Canada, China, Croatia, Denmark, Estonia, Finland, France, Gabon, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea (Republic Of), Kuwait, Lithuania, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uzbekistan, Viet Nam.
Product codes and lots: Model Numbers: 5590000-20: REV2A1900002CN, REV2A2000013CN, REV2A2000025CN, REV2A2000006CN, REV2A2000003CN, REV2A2000015CN, REV2A1900003CN, REV2A2000007CN, REV2A2000022CN, REV2A2000010CN, REV2A2000030CN, REV2A2000029CN, REV2A2000017CN, REV2A2000001CN, REV2A2000002CN, REV2A2000031CN, REV2A2000020CN, REV2A2000024CN, REV2A2000023CN, REV2A2000012CN, REV2A2000016CN, REV2A1900001CN, REV2A2000027CN, REV2A2000028CN, REV2A2000018CN, REV2A1900005CN, REV2A2000009CN, REV2A2000026CN, REV2A2000021CN, REV2A2000011CN 5590000-21: xxx, xxx, xxx* (66 units) *serial number information current as of 01/21/2021.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1129-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1129-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-24	2021-02-17
Z-1130-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-24	2021-02-17

Product code JAK

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)