LIFEPAK CR Plus and/or LIFEPAK EXPRESS are Automatic External… — Class II medical device recall Z-2100-2016
Terminated recall by Physio-Control, Inc., reported 2016-07-06, distributed nationwide. LIFEPAK CR Plus Automated External Defibrillators (AED) or LIFEPAK EXPRESS AED may fail to initiate voice prom
| Recall number | Z-2100-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Physio-Control, Inc., Redmond, WA, United States |
| Recall initiated | 2016-05-25 |
| Classified | 2016-06-29 |
| Reported by FDA | 2016-07-06 |
| Terminated | 2018-09-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BR, BS, CA, CH, CL, CN, CY, CZ, DE, DK, ES, FI, FR, GB, GR, HK, HR, HU, ID, IE, IL, IN, IS, IT, JP, KE, LT, LU, MT, MX, NL, NO, NZ, PH, PL, PT, QA, SA, SE, SG, SI, SK, TR, TW, ZA |
| Reason classes | device malfunction |
Product
LIFEPAK CR Plus and/or LIFEPAK EXPRESS are Automatic External Defibrillator(s) and are non-wearable. LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators are intended for use on patients in cardiac arrest.
Reason for recall
LIFEPAK CR Plus Automated External Defibrillators (AED) or LIFEPAK EXPRESS AED may fail to initiate voice prompts when the ON/OFF button is pressed and the lid is opened due to an internal component (reed switch) that can intermittently become fixed in the closed position. A defibrillator in this condition will fail to deliver a shock, with the potential result that therapy is not delivered and a patient is not resuscitated.
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-2100-2016. 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.