FDA Device recall Z-2100-2016

LIFEPAK CR Plus and/or LIFEPAK EXPRESS are Automatic External Defibrillator(s) and are non-wearable

FDA Device
Class II
terminated
Published 2016-07-06

On 2016-07-06 the FDA classified a Class II recall of LIFEPAK CR Plus and/or LIFEPAK EXPRESS are Automatic External Defibrillator(s) and are non-wearable by Physio Control, citing 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….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2100-2016
Classification	Class II
Status	terminated
Initiated	2016-05-25
Published	2016-07-06
Last updated	2026-09-13 11:54 UTC
Company	Physio Control
Distribution	US

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

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.

Identifiers

code_info	******Serial numbers of devices distributed in the US ******* 42871736, 42871737, 42871738, 42871748, 42871751… ****Serial numbers of devices distributed in the US ********* 42871736, 42871737, 42871738, 42871748, 42871751, 42871754, 42871756, 42871761, 42871763, 42871771, 42897196, 42897198, 42897203, 42897205, 42897206, 42897207, 42897208, 42897210, 42897211, 42897212, 42897215, 42897216, 42897217, 42897218, 42897221, 42897222, 42897227, 42897228, 42897235, 42897236, 42897237, 42897238, 42897239, 42897240, 42897244, 42897246, 42897247, 42897248, 42897252, 42897255, 42897256, 42897258, 42897260, 42897264, 42897265, 42897291, 42897295, 42897296, 42897297, 42897298, 42897299, 42897304, 42897305, 42897306, 42897308, 42897309, 42897310, 42897311, 42897312, 42897313, 42897314, 42897317, 42897318, 42897319, 42897322, 42897323, 42897324, 42897325, 42897326, 42897329, 42897335, 42897336, 42897345, 42897346, 42897347, 42897348, 42897349, 42897350, 42897351, 42897354, 42897355, 42897356, 42897357, 42897358, 42897361, 42897364, 42897365, 42897366, 42897367, 42897368, 42897369, 42897372, 42897373,

code_info

********Serial numbers of devices distributed in the US *********** 42871736, 42871737, 42871738, 42871748, 42871751…

********Serial numbers of devices distributed in the US *********** 42871736, 42871737, 42871738, 42871748, 42871751, 42871754, 42871756, 42871761, 42871763, 42871771, 42897196, 42897198, 42897203, 42897205, 42897206, 42897207, 42897208, 42897210, 42897211, 42897212, 42897215, 42897216, 42897217, 42897218, 42897221, 42897222, 42897227, 42897228, 42897235, 42897236, 42897237, 42897238, 42897239, 42897240, 42897244, 42897246, 42897247, 42897248, 42897252, 42897255, 42897256, 42897258, 42897260, 42897264, 42897265, 42897291, 42897295, 42897296, 42897297, 42897298, 42897299, 42897304, 42897305, 42897306, 42897308, 42897309, 42897310, 42897311, 42897312, 42897313, 42897314, 42897317, 42897318, 42897319, 42897322, 42897323, 42897324, 42897325, 42897326, 42897329, 42897335, 42897336, 42897345, 42897346, 42897347, 42897348, 42897349, 42897350, 42897351, 42897354, 42897355, 42897356, 42897357, 42897358, 42897361, 42897364, 42897365, 42897366, 42897367, 42897368, 42897369, 42897372, 42897373,

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Other recalls by Physio Control

LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-0019…
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PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI code: 00721902629013 Catalog Numbe…
FDA Device · Class II · 2026-03-18 · Physio Control
LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK CR2 defibrillator is indi…
FDA Device · Class II · 2025-09-10 · Physio Control
LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 883873871690 V15-2-000051 / 99577-000046 / 883873988022 V15-…
FDA Device · Class II · 2025-09-10 · Physio Control
LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000025 / 885074698953 33…
FDA Device · Class II · 2025-09-10 · Physio Control

All Physio Control recalls

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2100-2016%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.