Philips ECG Sync Cables Recalled for Electrical Interference Risk
Philips is recalling ECG sync cables used with HeartStart monitors because electrical interference can cause misinterpretation of heart signals or interrupt pacing.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where electrical interference can interrupt pacing or misinterpret heart signals, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Philips Electronics North America Corporation is recalling 18,604 ECG Out Cables (models M1783A and M5526A) used with Philips HeartStart MRx, HeartStart XL, and HeartStart XL+ monitor/defibrillators. These cables are used to connect auxiliary bedside monitors for synchronized cardioversion and transcutaneous pacing.
The recall is due to a risk that electrical fast transients (EFTs) from AC power can interfere with the device. On HeartStart MRx and HeartStart XL units, this interference can be misinterpreted as an R-wave. On HeartStart XL+ units, the interference can disable ECG monitoring and potentially interrupt demand mode pacing.
The affected cables were distributed worldwide, including in the United States and numerous other countries. Users should stop using the affected cables and contact Philips for instructions on replacement or repair.
The recalled product
- Product
- ECG Out Cable,for use with a Philips ALS monitor/ defibrillator and bedside monitor for Synchronized cardioversion and Transcutaneous pacing. M1783A/M5526A 12-pin Sync cables, used with HeartStart MRx and HeartStart XL and HeartStart XL+
- Manufacturer
- Philips Electronics North America Corporation
- Affected units
- 18,604
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 (1)
- near the end with the ¿ inch phone plug.
Distribution
Distributed nationwide across the United States.
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