Z-1623-2015Class II

CT LightSpeed 16 and Discovery ST Pet/CT DST. Catalogue # 2339985. Designed to be a head and whole body CT...

Name: Z-1623-2015 CT LightSpeed 16 and Discovery ST Pet/CT DST. Catalogue # 2339985. Designed to be a head and whole body CT...
Creator: GE Healthcare
Published: 2015-04-22
License: https://open.fda.gov/license/

GE Healthcare / initiated 2015-04-22 / Terminated / root cause: manufacturing process

FDA source

GE Healthcare began a recall of CT LightSpeed 16 and Discovery ST Pet/CT DST. Catalogue # 2339985. Designed to be a head and whole body CT scanner utilizing a new solid state detector on 2015-04-22. FDA classified it as Class II and gives the reason as "GE Healthcare has become aware that 3 bolts that secure a power supply to the rotating side of the gantry were over-torqued on certain Lightspeed 16 CT scanner or PET/CT DST Scanner.. In the unlikely event that the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1623-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-22
Posted: 2015-05-15
Terminated: 2015-07-15
Recalling firm: GE Healthcare
Product: CT LightSpeed 16 and Discovery ST Pet/CT DST. Catalogue # 2339985. Designed to be a head and whole body CT scanner utilizing a new solid state detector.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: GE Healthcare has become aware that 3 bolts that secure a power supply to the rotating side of the gantry were over-torqued on certain Lightspeed 16 CT scanner or PET/CT DST Scanner.. In the unlikely event that the component becomes loose on the CT gantry during operation, it could result in serious bodily injury if the component were expelled. There were no incidents or injuries reported as a res
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# 25461 dated April 22, 2015. The letter was addressed to Hospital Administrators / Risk Managers, Managers of Radiology/Cardiology, and Radiologists/Cardiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. The letter stated that customers can continue to use their device. If the error occurs, then stop using the system and call a service representative to bring the system back into proper operation. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. UPDATED: Consignees were sent on 5/14/2015 a second GE Healthcare "Urgent Medical Device Correction" letter dated May 14th, 2015. The letter was to incorporate and additional unit being recalled.
Quantity in commerce: 4 USA
Distribution: Distributed to the states of MN, FL & TX.
Product codes and lots: Mfg Lot or Serial # System ID 00000331100CN8 904223CT 00000345975CN7 409838LS16 00000337343CN8 512OCCT 00000344962CN6 INSIGHTPCT1356

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1623-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1623-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-27	2015-05-15

Product code JAK

K013561Class IILightspeed 4.0 CT Scanner SystemGE Medical Systems / cleared 2001-11-08

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)