Z-2802-2015Class II

PET Discovery LS

Name: Z-2802-2015 PET Discovery LS
Creator: GE Healthcare
Published: 2015-07-17
License: https://open.fda.gov/license/

GE Healthcare / initiated 2015-07-17 / Terminated / root cause: manufacturing process

FDA source

GE Healthcare began a recall of PET Discovery LS on 2015-07-17. FDA classified it as Class II and gives the reason as "Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Discovery LS PET CT scanner". 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-2802-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-17
Posted: 2015-09-21
Terminated: 2016-03-08
Recalling firm: GE Healthcare
Product: PET Discovery LS
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Discovery LS PET CT scanner.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: GE Healthcare sent an "Urgent Medical Device Correction" letter to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. Ref# 25463
Quantity in commerce: 6
Distribution: Worldwide Distribution - US (nationwide) and to the countries of : ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHINA, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, HUNGRY, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA, MEXICO, NORWAY, POLAND, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN and UNITED KINGDOM.
Product codes and lots: 00000336259CN7 82445150008 00000357522CN2 RADNETPT608 00000316259CN1 210351MSDLS 00000293036CN0 352597PET 00000843236YM1 607766DLSPET 00000003458PT7 337407DLS

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2802-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2801-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-30	2015-09-21
Z-2802-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-30	2015-09-21
Z-2803-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-30	2015-09-21

Product code KPS

K040172Class IIModification to Ge Discovery Ls SystemGE Medical Systems / cleared 2004-04-07

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)