Z-0105-06

Sopha Medical Vision DST / DST-XL Digital vatiable angle Nuclear Imaging System

Name: Z-0105-06 Sopha Medical Vision DST / DST-XL Digital vatiable angle Nuclear Imaging System
Creator: General Electric Med Systems LLC
Published: 2005-09-27
License: https://open.fda.gov/license/

GE Healthcare / initiated 2005-09-27 / Terminated / root cause: manufacturing process

FDA source

General Electric Med Systems LLC began a recall of Sopha Medical Vision DST / DST-XL Digital vatiable angle Nuclear Imaging System on 2005-09-27. The reason FDA records is "Cracked welds on the main rotation shaft could potentially lead to the collapse of the gantry yokes that support the detectors if the system is continued to be used after the weld has completely fractured". 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-0105-06
Status: Terminated
Initiated: 2005-09-27
Posted: 2005-10-28
Terminated: 2006-12-26
Recalling firm: GE Healthcare
Product: Sopha Medical Vision DST / DST-XL Digital vatiable angle Nuclear Imaging System
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: Cracked welds on the main rotation shaft could potentially lead to the collapse of the gantry yokes that support the detectors if the system is continued to be used after the weld has completely fractured.
Root cause tag: manufacturing process
FDA root cause: Other
Action: GE Healthcare issued an Urgent Safety Notice, dated 07/22/05, to all affected sites. This letter describes the potential hazard, its waring signs and the additional corrective actions that will be taken by GE Healthcare.
Quantity in commerce: 140 (80 US and 60 OUS)
Distribution: Within the US to include: AL, AZ, CA, DE, FL, GA, IA, IL, KS, MA, MD, MI, NC, NJ, NY, OH, PA, SC, TX, VA, WI and WV. OUS to include: Belgium, Brazil, Canada, China, Czech Republic, Egypt, France, Germany, Greece, Italy, Korea, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Sinapore, Spain, Sweden and United Kingdom
Product codes and lots: Cameras affected by this safety notice are labeled with the SOPHA MEDICAL logo. STATIF DST and STATIF DST-XL model 100, serial numbers 001-264. The label is located on the inner side of the gantry cover. All affected cameras were manufactured prior to 1997 by Sopha Medial (SMV), which was subsequently acquired by GE Healthcare in 2000.

Product code KPS

K942837Class IIDst-XlSopha Medical Systems, Inc. / cleared 1995-01-05

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)