Philips MultiDiagnost Eleva system, a diagnostic-imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications. FCO 70800114.
This recall has been terminated (originally issued March 16, 2011).
- Recall Initiated
- October 7, 2010
- Posted
- March 16, 2011
- Terminated
- February 23, 2012
- Recall Number
- Z-1656-2011
- Quantity
- 89 units distributed in US
- Firm Location
- Bothell, WA
- Official Source
- View on FDA website ↗
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.
Distribution
Devices were distributed through out the US.
Lot / Code Info
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.
Root Cause
Nonconforming Material/Component
Action Taken
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.