Physio-Control Recalls LIFEPAK AEDs Due to Shock Delivery Failure Risk
Physio-Control is recalling LIFEPAK CR Plus and EXPRESS AEDs because a faulty component may prevent the device from delivering a shock during cardiac arrest.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device failure that can result in the non-delivery of life-saving therapy (shock) during cardiac arrest, posing a significant risk of serious injury or death.
Plain-English summary
Physio-Control, Inc. is recalling LIFEPAK CR Plus and LIFEPAK EXPRESS Automated External Defibrillators (AEDs). The recall involves 25,178 units, with 10,418 distributed in the United States and 14,760 distributed outside the US.
The devices are being recalled because an internal component, known as a reed switch, can intermittently become fixed in the closed position. This defect may cause the AED to fail to initiate voice prompts when the ON/OFF button is pressed and the lid is opened. Consequently, the defibrillator may fail to deliver a shock, potentially resulting in therapy not being delivered and a patient not being resuscitated.
The affected devices were distributed worldwide, including nationwide in the US (including Guam and Puerto Rico) and in numerous other countries. Consumers and healthcare facilities should check their device serial numbers against the list provided in the official recall notice to determine if their unit is affected.
The recalled product
- 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.
- Manufacturer
- Physio-Control, Inc.
- Category
- Medical Device — Defibrillator
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- ********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
Distribution
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