Food, drugs, devices › Physio-Control, Inc.
Device recall: LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051
FDA enforcement event 93233 is a device recall by Physio-Control, Inc. of Redmond, WA, initiated 29 Sep 2023 and classified Class II, with 10 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 917 device enforcement events initiated in 2023 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Physio-Control, Inc. has 27 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Physio-Control, Inc., Redmond, WA.
Reason for recall
"Their is a potential for battery pins to become loose within the defibrillator resulting in power issues."
Distribution
"US Nationwide distribution in the states of AZ, CA, NC, NJ, NY."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0296-2024 | LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051 | 1 unit | Class II | Ongoing | 22 Nov 2023 |
| Z-0297-2024 | LIFEPAK 15, REF: 99577-000055, Part Number V15-2-000061 | 8 yrs. | Class II | Ongoing | 22 Nov 2023 |
| Z-0298-2024 | LIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067 | 1 unit | Class II | Ongoing | 22 Nov 2023 |
| Z-0299-2024 | LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602 | 5 units | Class II | Ongoing | 22 Nov 2023 |
| Z-0300-2024 | LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002 | 1 unit | Class II | Ongoing | 22 Nov 2023 |
| Z-0301-2024 | LIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020 | 4 units | Class II | Ongoing | 22 Nov 2023 |
| Z-0302-2024 | LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021 | 1 units | Class II | Ongoing | 22 Nov 2023 |
| Z-0303-2024 | LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022 | 8 units | Class II | Ongoing | 22 Nov 2023 |
| Z-0304-2024 | LIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023 | 1 unit | Class II | Ongoing | 22 Nov 2023 |
| Z-0305-2024 | LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026 | 2 units | Class II | Ongoing | 22 Nov 2023 |
Context
Other enforcement events for Physio-Control, Inc.
All 27 events for Physio-Control, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Their is a potential for battery pins to become loose within the defibrillator resulting in power issues."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution in the states of AZ, CA, NC, NJ, NY."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.