LIFEPAK 15 MONITOR/DEFIBRILLATOR that was either manufactured with or… — Class II medical device recall Z-0816-2020
Terminated recall by Physio-Control, Inc., reported 2020-01-22, distributed nationwide. Monitor/Defibrillator may not deliver a shock after the "Shock" button on the keypad is pressed as a result of
| Recall number | Z-0816-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Physio-Control, Inc., Redmond, WA, United States |
| Recall initiated | 2019-12-20 |
| Classified | 2020-01-16 |
| Reported by FDA | 2020-01-22 |
| Terminated | 2022-10-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, AW, BB, BE, BH, BR, CA, CH, CL, CN, CR, CY, CZ, DE, DK, DZ, EC, EG, ES, FI, FR, GB, GR, HK, HR, HU, ID, IE, IL, IQ, IS, IT, JP, KE, KR, KW, KY, LB, LT, LU, LV, MA, MT, MX, MY, NG, NL, NO, NZ, OM, PK, PL, PT, QA, RO, RS, SA, SE, SG, SI, TH, TR, TT, TW, UA, VE, ZA |
| Quantity | 29,952 |
| Serial numbers | 37923203, 37923205, 37923208, 37923213, 37924152, 37928794, 37928964, 37930942, 37930944, 37930964, 37930966, 37930977, 37930990, 37930993, 37931003, 37933241, 37933244, 37933249, 37933250, 37933262, 37937842, 37937843, 37937848, 37937849, 37937851 and 475 more |
Product
LIFEPAK 15 MONITOR/DEFIBRILLATOR that was either manufactured with or received an upgrade kit that contained an affected keypad.
Reason for recall
Monitor/Defibrillator may not deliver a shock after the "Shock" button on the keypad is pressed as a result of oxidation that has formed over time within the button.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0816-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.