Precision 500D Classical R&F System with control room PC; Image-intensified fluoroscopic x-ray system; ; Model Number: 5117866-27.
FDA Recall Z-0274-2008 · Posted 2008-08-02
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Recalling FirmGE Healthcare
Recall StatusTerminated
Product CodeJAA
Date Initiated2007-08-01
Date Terminated2008-09-10
Product Quantity101
Reason for Recall
Inaccurate cassette size display reading/ Inaccurate mAs reading: 1. When the device is in PBL mode and a larger film cassette is inserted into the table Bucky (replacing a smaller cassette) after a protocol is selected on the console, the collimator will not adjust to the larger cassette size. The collimator stays at the original smaller cassette size and allows the operator to take an exposure.
Firm Action
Consignees were notified by two "Product Safety Notification" letters on July 10, 2007. Each letter addressed one of the two safety issues with the affected product. The letters provided safety instructions on how avoid the software error and informed users that their representative would contact them to schedule a visit for a software correction installation.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution --USA including states of: AK, AL, AR, CA, CO, CT, FL, GA, IA, ID, IL ,IN, LA, MA, MD, MI, MO,MS, NC, ND, NE, NH, NJ, NM, NV, OH,OK, OR, PA, SC, SD, TN, TX, UT, VA, VT and WA; USA territory of: PR and countries: EGYPT, SAUDI ARABIA, MACEDONIA, FRANCE and GREAT BRITAIN.
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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