FDA Device recall Z-0294-2018
LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273 Product Usage: The LIFEPAK 20e defibrillator/monitor is intended for use in the hospital, physic…
- FDA Device
- Class I
- terminated
- Published 2018-01-17
On 2018-01-17 the FDA classified a Class I recall of LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273 Product Usage: The LIFEPAK 20e defibrillator/monitor is intended for use in the hospital, physic… by Physio Control, citing physio-Control is aware that some devices have had power-related failures as customers prepared their device for initial deployment or during use within the first year of distribu….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0294-2018 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2017-12-04 |
| Published | 2018-01-17 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Physio Control |
| Distribution | n/a |
Product
LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273 Product Usage: The LIFEPAK 20e defibrillator/monitor is intended for use in the hospital, physician s office, and clinic setting by personnel who are authorized by a physician/medical director. It is intended for use on a crash cart as well as for portable emergency response throughout a hospital.
Reason
Physio-Control is aware that some devices have had power-related failures as customers prepared their device for initial deployment or during use within the first year of distribution. The symptoms of these failures may include unexpected power on and power off, device lock-up, or a failure to power on or off, any of which has the potential to result in a failure to deliver therapy to the patient and serious injury or death.
Identifiers
| code_info | 45039371 45041785 45044636 45057093 45067882 45073270 45450645 45491315 45491441 45491644 45808476 45813092…45039371 45041785 45044636 45057093 45067882 45073270 45450645 45491315 45491441 45491644 45808476 45813092 45598878 45599806 45073745 45435012 45439562 45278002 45307727 45307732 45307742 45308078 45309308 45309310 45309317 45309923 45310487 45310523 45489720 45321756 45605113 45167375 45160349 45540221 45066559 45551722 45253909 45635361 45313588 45314492 45321757 45173154 45807047 45694119 45041460 45041335 45041572 45486374 45439205 45451242 45468563 45860139 45321722 45399194 45040553 45937962 45860005 45889371 45890053 45890181 45890310 45890600 45168699 45486960 45490591 45802737 45802739 45949393 45874190 45802736 45057137 45173422 45175430 45175496 45257327 44963488 45045796 45045990 45046296 45074231 45247320 45314855 45391419 45445721 45579549 45624977 45625366 45933892 45935769 45935894 45936081 45936175 45936811 45371506 45399258 45584143 45584240 45584531 45591943 45592637 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0294-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.