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Terminated

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

FDA Recall Z-0105-06 · Posted 2005-10-28

Recalling FirmGeneral Electric Med Systems LLC
Recall StatusTerminated
Product CodeKPS
Date Initiated2005-09-27
Date Terminated2006-12-26
Product Quantity140 (80 US and 60 OUS)

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.

Firm 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.

Root Cause

Other

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K942837DST-XLSopha Medical Systems, Inc. · 1995-01-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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