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Z-2471-2010

Philips Allura XPER 10/10 Angiographic X-ray system. This system with Velara Generator can be identified as...

Philips North America LLC / initiated 2008-10-23 / Terminated
FDA source (opens on fda.gov)

Philips Medical Systems North America Co. Phillips began a recall of Philips Allura XPER 10/10 Angiographic X-ray system. This system with Velara Generator can be identified as type number 9890 000 6501 * (number located on the... on . The reason FDA records is "A high voltage reliability issue resulting in the loss of the x-ray generation and this can cause an intermittent stop of fluoro acquisition and exposure during an examination without warning and hence no image on the...". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-2471-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Philips North America LLC
Product
Philips Allura XPER 10/10 Angiographic X-ray system. This system with Velara Generator can be identified as type number 9890 000 6501 * (number located on the generator cabinet). Intended use for Angiographic X-ray system with and without a solid state X-ray imaging device for cardiovascular and vascular diagnostic and interventional procedures.
Product code
IZI System, X-Ray, Angiographic
Reason for recall
A high voltage reliability issue resulting in the loss of the x-ray generation and this can cause an intermittent stop of fluoro acquisition and exposure during an examination without warning and hence no image on the display.
FDA root cause
Other
Action
The firm, Philips, sent "URGENT-Device Correction" letters dated November 10, 2008, to their customers and informed them about the reliability issue in the Allura XPER and Integris X-ray systems with the High Voltage Velera (HV) Generator. This reliability issue can lead to a system error causing intermittent loss of fluro and/or exposure acquisition, potentially resulting in the loss of the X-ray image on the display. The customers are advised if they experience High Voltage Generator reliability issue and the HV Generator stops working generating an O3EA error, a cold restart is required and reboot the system when the X-Ray image disappears. The firm will implement multiple mandatory Field Change Orders (FCOs) to solve the Generator reliability by updating the software for each X-ray system. The customers could contact Philips Care Center at 800-722-9377, #5, #4, #1 for any questions regarding this recall or 425-487-7469.
Quantity in commerce
70 units in US
Distribution
Worldwide distribution.
Product codes and lots
Devices are identified as Site Numbers:  538028, 536037, 536035, 536034, 536031, 536042, 536028, 537631, 538157, 537804, 538409, 538516, 538514, 539628, 540237, 540184, 539326, 542714, 542557, 538387, 542413, 543200, 543411, 541577, 543879, 543289, 541589, 544395, 545025, 544433, 545604, 545753, 541590, 546013, 548140, 546569, 543989, 547922, 548288, 547173, 545997, 545884, 549903, 551855, 547769, 41444647, 41455885, 41455897, 545396, 554802, 549368, 555293, 547823, 555834, 555299, 41443804, 554970, 41444650, 41455920, 41445448, 41445501, 41780160, 41445538, 41443647, 42064724, 42057324, 103281, 103283, 530653, and 505903.