—#144959

Product

Extended Brilliance Workspace NM Nuclear medicine image display and processing application suite. AutoSPECT Pro Software Application. Philips Medical Systems, Cleveland, OH. Provides software applications used to process, analyze, and display medical images/data.

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K090403
Affected lot / code info: M/N 882489; S/N: 66794, 66798, 66836, 66009,66011, 67154, 66828, 67058, 67050, 67031, 67284, 66332, 66335, 66397, 67026, 67040, 66084, 66089, 66092, 67007, 67011, 67226, 66956, 66454, 66447, 66413, 66129, 66128, 66300, 66023, 11728, 66000, 66938, 67270, 67252, 66571, 66443, 66324, 66869, 68477, 66682, 66815, 66284, 67263, 66265, 66277, 66880, 66892, 66258, 66079, 66181, 66451, 66627, 66187, 66806, 67016, 67008, 66706, 66745, 66817, 66822, 66910, 66908, 66811, 67087, 67094, 66241, 66825, 66632, 66624, 66854, 66689, 66690, 66906, 66792, 67173, 67069, 67166, 68290, 67182, 66785, 67292, 67286, 66768, 66769, 66550, 66113, 67220, 67193, 67186, 66657, 66668, 66564, 66065, 67065, 67208, 67204, 66818, 66819, 67122, 66818, 66819, 66456, 67212, 66019, 67057, 67172, 67157, 67167, 67162, 66737, 68361, 66183, 66368, 66387, 66376, 66415, 66136, 66137, 66960, 66958, 67142 & 67165.

Why it was recalled

The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with detectors positioned at 90 or 180 relative to one another. However, certain gamma cameras allow for other relative detector angles. Data acquired at these other angles will not be correctly reconstructed by AutoSPECT Pro and the results will likely be erroneous.

Root cause (FDA determination)

Software design

Action the firm took

On March 4, 2016, the firm sent an URGENT - Field Safety Notice Medical Device Correction letter to their customers. The letter identified the affected device, the reason for the recall, and under what circumstances the problem occurs. Customers are to contact Philips as described if they are unsure whether their gamma cameras supports the modes. The firm will implement the AutoSPECT Pro software upgrade and contact customers to schedule the appointment. If further assistance or support is needed, customers are to contact their local Philips representative.

Recalling firm

Firm: Philips Medical Systems (Cleveland) Inc
Address: 595 Miner Rd, Cleveland, Ohio 44143-2131

Distribution

Distribution pattern: Worldwide Distribution -- US, including the states of CO, DE, FL, GA, IL, IN, KS, MO, NC, NV, NY, OH, OR, PA, TN & TX; and, the countries of Australia, Austria, Belgium, Canada, China, Denmark, Egypt, France, Germany, Greece, Ireland, Israel, Italy, Lebanon, Malaysia, Saudi Arabia, Slovenia, South Africa, Switzerland, Turkey, & United Kingdom.

Timeline

Recall initiated: 2016-03-04
Terminated: 2018-07-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #144959. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.