510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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Z-1656-2011

Philips MultiDiagnost Eleva system, a diagnostic-imaging device intended for radiographic, fluoroscopic...

Philips North America LLC / initiated 2010-10-07 / Terminated / root cause: manufacturing process
FDA source (opens on fda.gov)

Philips Medical Systems North America Co. Phillips began a recall of Philips MultiDiagnost Eleva system, a diagnostic-imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications. FCO... on . The reason FDA records is "A wire in the connector of the Generator Grid Switch Supervisor box might short-circuit between 12V power and ground, and it will cause a System breakdown". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1656-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Philips North America LLC
Product
Philips MultiDiagnost Eleva system, a diagnostic-imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications. FCO 70800114.
Product code
IZI System, X-Ray, Angiographic
Reason for recall
A wire in the connector of the Generator Grid Switch Supervisor box might short-circuit between 12V power and ground, and it will cause a System breakdown.
Root cause tag
manufacturing process
FDA root cause
Nonconforming Material/Component
Action
On 10/15/2010, Philips began sending out the URGENT-Device Correction Notice Failure Causing the Generator to Stop Working notification letter to their consignees. The consignees were informed that a short circuit may occur due to a faulty wire connection in the Supervisor Box Connector in the Generator, and it will cause the generator stops working. When the system fails during a critical interventional case, this may cause risk to patients (no Fluoro available). The systems involved in this recall are Allura Xper with the Velara Generator, Allura Integris with OMCP Generator, MultiDiagnost Eleva, and OmniDiagnost Eleva Imaging system. Consignees can contact Philips Healthcare Call Center at 800-722-9377, #5 and Reference FCO 70800114, 70800115, 72200184, and 72200185.
Quantity in commerce
89 units distributed in US
Distribution
Devices were distributed through out the US.
Product codes and lots
505345, 505346, 506236, 530589, 530777, 532140, 532151, 532213, 532703, 533473, 533559, 534247, 535714, 535767, 536019, 536091, 536146, 536720, 536935, 537083, 537669, 537787, 539598, 539990, 540252, 541263, 543272, 544059, 545014, 545156, 545198, 545841, 546031, 546578, 549417, 551519, 551714, 553287, 553435, 553838, 554283, 554284, 554633, 554640, 556197, 556369, 557258, 41444651, 41445097, 41445127, 41445131, 41445221, 41445237, 41445464, 41445652, 41445800, 41445927, 41455927, 41643223, 41783749, 41849575, 41954854, 42549980, 42799914, 42892004, 42892024, 42892425, 43319037, 43386703, 43443091, 43453378, 43721197, 44146025, 44401636, 44653739, 44654723, 45629333, 47130091, 47190569, 47413010, 47607148, 47783855, 49136896, 49144094, 49903432, 50003342, 50037841, 50416595, and 51599597.