FDA Device recall Z-0926-2023
SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000
- FDA Device
- Class I
- terminated
- Published 2023-01-25
On 2023-01-25 the FDA classified a Class I recall of SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000 by Cardiac Assist, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0926-2023 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2022-12-05 |
| Published | 2023-01-25 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Cardiac Assist |
| Distribution | US |
Product
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 extracorporeal circuit.
Reason
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.
Identifiers
| code_info | Model No. 5900-0000 - UDI/DI 00814112020562 Model No. 5900-0001 - UDI/DI 00814112020623 Serial Numbers C00115 C50232 C…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0926-2023%22
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