Z-2187-2017Class II

GE Healthcare lnnova IGS 540 ACT X-ray system

Name: Z-2187-2017 GE Healthcare lnnova IGS 540 ACT X-ray system
Creator: GE Healthcare, LLC
Published: 2017-05-19
License: https://open.fda.gov/license/

GE Healthcare / initiated 2017-05-19 / Terminated / root cause: software

FDA source

GE Healthcare, LLC began a recall of GE Healthcare lnnova IGS 540 ACT X-ray system on 2017-05-19. FDA classified it as Class II and gives the reason as "It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2187-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-19
Posted: 2017-06-12
Terminated: 2018-07-29
Recalling firm: GE Healthcare
Product: GE Healthcare lnnova IGS 540 ACT X-ray system
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
Root cause tag: software
FDA root cause: Software design
Action: GE Healthcare proposed action to bring defect into compliance : 1. Inform users of the potential for this issue to occur and instruct users as to the actions to take in the event of an Emergency Stop actuation during prep-delay. 2. Provide an update to product labeling for users that includes this information. GE Healthcare will include the updated product labeling with all current production systems. 3. Make modifications during the next scheduled product update to prevent this "race" condition from occurring in newly produced systems. CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. Any future customer notification letters to be sent must comply with the requirements of 21 CFR 1003.21. This includes, but is not limited to, the prescribed packaging and the statement that you will remedy the defect or bring the product into compliance at no charge. 3.You complete this recall by September 1, 2017. Report any failures regarding this recall immediately to the District Recall Coordinator. For further questions, please call (262) 513-4122.
Quantity in commerce: 10,884
Distribution: Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Japan, Jordan, Kazakhstan, Korea ( Republic of) Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritania, Mexico, Moldova, Morocco, Nambia, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Serbia, Reunion, Romania, Russia, Rwanda, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietam and Yemen.
Product codes and lots: n/a

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2187-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2181-2017	Class II	Terminated	FDA Mandated	2017-06-21	2017-06-12
Z-2182-2017	Class II	Terminated	FDA Mandated	2017-06-21	2017-06-12
Z-2183-2017	Class II	Terminated	FDA Mandated	2017-06-21	2017-06-12
Z-2184-2017	Class II	Terminated	FDA Mandated	2017-06-21	2017-06-12
Z-2185-2017	Class II	Terminated	FDA Mandated	2017-06-21	2017-06-12
Z-2186-2017	Class II	Terminated	FDA Mandated	2017-06-21	2017-06-12
Z-2187-2017	Class II	Terminated	FDA Mandated	2017-06-21	2017-06-12
Z-2188-2017	Class II	Terminated	FDA Mandated	2017-06-21	2017-06-12
Z-2189-2017	Class II	Terminated	FDA Mandated	2017-06-21	2017-06-12
Z-2190-2017	Class II	Terminated	FDA Mandated	2017-06-21	2017-06-12
Z-2191-2017	Class II	Terminated	FDA Mandated	2017-06-21	2017-06-12
Z-2192-2017	Class II	Terminated	FDA Mandated	2017-06-21	2017-06-12
Z-2193-2017	Class II	Terminated	FDA Mandated	2017-06-21	2017-06-12
Z-2194-2017	Class II	Terminated	FDA Mandated	2017-06-21	2017-06-12
Z-2195-2017	Class II	Terminated	FDA Mandated	2017-06-21	2017-06-12
Z-2196-2017	Class II	Terminated	FDA Mandated	2017-06-21	2017-06-12

Product code JAK

K091673Class IIGe Lightspeed Act Fp16Ge Medical Systems, Inc. / cleared 2009-06-24

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)