Revolution XR/d systems with control room PC model 5117866-2 with Software collector 5194381. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188. Intended for use in generating Tomographic images of human anatomy.
FDA Recall Z-0003-2009 · Posted 2009-09-22
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Recalling FirmGE Medical Systems, LLC
Recall StatusTerminated
Product CodeKPR
Date Initiated2008-02-14
Date Terminated2011-12-18
Product Quantity83 (63 USA, 20 OUS)
Reason for Recall
GE Healthcare has recently become aware of an error in the generator software on the Revolution XR/d
configured with HP 8200 PC consoles that reports a mAs reading that is higher than is actually exposed to patients.
Firm Action
Consignees were sent a GE Healthcare "Product Safety Notification" letter dated March 7, 2008. The letter was addressed to Hospital Administrators, Mangers of Radiology, and Radiologists. The letter listed the Safety Issue, Affected Product, Safety Instructions, and Contact Information.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, ID, IL, IN, LA, MA, MI, MO, NY, NC, OH, OR, PA, SC, SD, TN, TX, WA, and WI and countries of Canada, China, Japan, Korea, and Taiwan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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