Cardiac Assist, Inc: SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFESPARC, CONTROLLER ONLY - 5900-0001. Component of LifeSPARC System, used to pump the blood through an ext

Hazard

A software update (v1.1.5) has been developed to address the issue of Critical Failure which can occur on the LifeSPARC Controller. The Critical Failure was first addressed in the firm's recall initiated July 21, 2022. During the Critical Failure, the software freezes or crashes and the screen does not display data.

Details from the source

Reason for recall: A software update (v1.1.5) has been developed to address the issue of Critical Failure which can occur on the LifeSPARC Controller. The Critical Failure was first addressed in the firm's recall initiated July 21, 2022. During the Critical Failure, the software freezes or crashes and the screen does not display data. Distribution: US Nationwide distribution. Quantity: 763 (US only) Lot/code info: Model No. 5900-0000 - UDI/DI 00814112020562 Model No. 5900-0001 - UDI/DI 00814112020623 Serial Numbers C00115 C50232 C50253 C50403 C00195 C50619 C50623 C50161 C50167 C50362 C50388 C50432 C50505 C00189 C50648 C50437 C50671 C50690 C00048 C00087 C50114 C50135 C00149 C50274 C50506 C50308 C50319 C00040 C00107 C50207 C50160 C50016 C50604 C50493 C50355 C50633 C00126 C00155 C50113 C00041 C00135 C00042 C00035 C50012 C50019 C50073 C00176 C50386 C50677 C00052 C00076 C00092 C50384 C50490 C50679 C00095 C50149 C00182 C50392 C50337 C50451 C50708 C50306 C50460 C50512 C50082 C50174 C00151 C50328 C50111 C50501 C00157 C50363 C50476 C50701 C50212 C50219 C50350 C00174 C00006 C50076 C50105 C50235 C50613 C50197 C50375 C50463 C50517 C50632 C50653 C50662 C00199 C00205 C50699 C50269 C50398 C50618 C50606 C50645 C50100 C50101 C50626 C50204 C50266 C50330 C50031 C50050 C50241 C50524 C00188 C00197 C50131 C50181 C50365 C00038 C50237 C00190 C50598 C50283 C00143 C50287 C50288 C50259 C50270 C00185 C50202 C00209 C50639 C00158 C50357 C50601 C50289 C50592 C50640 C50059 C50065 C50097 C50043 C50037 C50072 C50096 C50153 C50140 C50703 C50391 C50642 C50536 C50682 C50314 C50354 C50470 C50409 C50526 C50146 C50225 C50226 C50001 C50090 C00169 C00023 C00161 C50224 C50458 C50525 C50581 C50591 C50428 C50466 C00202 C00196 C50593 C50539 C50303 C00127 C00063 C50211 C50229 C50280 C00167 C50374 C50387 C00141 C00136 C00145 C50312 C00073 C50243 C00150 C50222 C50343 C50425 C00053 C00057 C50652 C00113 C00114 C50038 C50247 C50651 C506

UPC codes

00814112020562, 00814112020623

Source

Official record: FDA (Device enforcement) ↗

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