PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722223, (2) 7

Hazard

Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it will cause the fuses to trip and the system will become non-functional due to power loss, resulting in a potential delay of procedure or termination of procedure.

Details from the source

Reason for recall: Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it will cause the fuses to trip and the system will become non-functional due to power loss, resulting in a potential delay of procedure or termination of procedure. Distribution: Worldwide distribution - US Nationwide distribution in the states of NY, PA, PR, TN, TX, VA, WA and the countries of Algeria, Armenia, Austria, Brazil, China, Colombia, Croatia, Czech Republic, Ecuador, France, Germany, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Kazakhstan, Korea, Republic of Kuwait, Lithuania, Macao, Macedonia, Malaysia, Morocco, Netherlands, Norway, Oman, Palestine, Quantity: 10 units US; 124 units OUS Lot/code info: US: (1) Model 722223 SN: 580 (01)00884838099241(21)580 (2) Model: 722224 SN: UDI: 1518 (01)00884838099258(21)1518 1317 (01)00884838099258(21)1317 1221 (01)00884838099258(21)1221 845 (01)00884838099258(21)845 974 (01)00884838099258(21)974 905 (01)00884838099258(21)905 (3) Model: 722225 227 (01)00884838099265(21)227 (4) Model: 722226 441 (01)00884838099272(21)441 398 (01)00884838099272(21)398 OUS: 179 (01)00884838099265(21)179 145 (01)00884838099265(21)145 223 (01)00884838099265(21)223 226 (01)00884838099265(21)226 232 (01)00884838099265(21)232 196 (01)00884838099265(21)196 159 (01)00884838099265(21)159 200 (01)00884838099265(21)200 234 (01)00884838099265(21)234 206 (01)00884838099265(21)206. 412 (01)00884838099272(21)412 425 (01)00884838099272(21)425 420 (01)00884838099272(21)420 355 (01)00884838099272(21)355 393 (01)00884838099272(21)393 407 (01)00884838099272(21)407 402 (01)00884838099272(21)402 527 (01)00884838099272(21)527 479 (01)00884838099272(21)479 509 (01)00884838099272(21)509 460 (01)00884838099272(21)460 505 (01)00884838099272(21)505 513 (01)00884838099272(21)513 485 (01)00884838099272(21)485 364 (01)00884838099272(21)364 507 (01)00884838099272(21)507 577 (01)00884838099272(21)577 476 (01)00884838099272(21)476 515 (01)00884838099272(21)515 596 (01)00884838099272(21)596 598 (01)00884838099272(21)598 521 (01)00884838099272(21)521 455 (01)00884838099272(21)455 589 (01)00884838099272(21)589 575 (01)00884838099272(21)575 522 (01)00884838099272(21)522 540 (01)008848380992

UPC codes

00884838099241, 00884838099258, 00884838099265, 00884838099272

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.