Philips Recalls ECG Out Cables Due to Electrical Interference Risk
Philips is recalling specific ECG out and sync cables because electrical interference may cause monitors to misinterpret signals or disable monitoring.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is classified as FDA Class II and involves a risk of harm (misinterpreted signals or interrupted pacing) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Philips Electronics North America Corporation is recalling specific ECG out cables and 12-pin sync cables used with HeartStart MRx and HeartStart XL monitor/defibrillators. The affected models are M1783A, M5526A, and 989803195641, manufactured between September 4, 2002, and October 8, 2014. A total of 15,811 units were distributed to 1,067 US customers, 163 in Canada, and 917 international customers.
The recall is issued because electrical fast transients (EFTs) can interfere with the ECG signal when these cables are used to connect an auxiliary bedside monitor to the main device. On HeartStart MRx and HeartStart XL units, this interference may be misinterpreted as an R-wave. On HeartStart XL+ units, EFT noise can disable ECG monitoring and potentially interrupt demand mode pacing. However, the manufacturer notes that using the ECG out cable for demand mode pacing is contrary to the device's Instructions for Use, which require a direct patient connection for that specific mode.
Healthcare facilities and users should stop using the affected cables and contact Philips for further instructions. The recall is classified as Class II by the FDA, indicating a reasonable probability of temporary or medically reversible adverse health consequences.
The recalled product
- Product
- ECG Out Cable - Heartstart MRx M1783A/M5526A 12-pin Sync cables All units of Philips sync cables model M1783A and M5526A as well as Philips ECG out cables model 989803195641. Manufactured - September 4, 2002 October 8, 2014
- Manufacturer
- Philips Electronics North America Corporation
- Affected units
- 15,811
Distribution
Distribution scope not specified by the agency.
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