Z-2803-2015Class II

PET Discovery ST 16

Name: Z-2803-2015 PET Discovery ST 16
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 ST 16 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-2803-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-17
Posted: 2015-09-21
Terminated: 2016-03-08
Recalling firm: GE Healthcare
Product: PET Discovery ST 16
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: 18
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: 00000407058CN7 B5127901 00000393804CN0 YE0524 00000007118PT3 A098PE01 00000005880PT0 853450026 00000295121CN8 469525DLS 00000331760CN9 256327PET 00000305946CN6 201599DST 00000314955CN6 RADNETPT1813 00000362166CN1 203694DST16 00000354677CN7 918744PETCT 00000359856CN2 713704DST 00000364001CN8 845454PCT 00000299430CN9 817927DST 00000011079PT1 662232DST 00000005835PT4 256705PS2 00000010481PT0 615320DST 00000005903PT0 856794DISCST 00000412917CN7 818DCCDST

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2803-2015
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

K041543Class IIGe Discovery StGE Healthcare / cleared 2004-06-22

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)