ECG Out Cable recall
ECG Out Cable,for use with a Philips ALS monitor/ defibrillator and bedside monitor for Synchronized cardioversion and Transcutaneous pacing.…
Why was ECG Out Cable recalled?
When a Philips monitor/defibrillator is receiving an ECG signal from an auxiliary bedside monitor via a sync cable, the following can occur if the monitor/defibrillator experiences interference from electrical fast transients (EFTs) while connected to AC power: On the HeartStart MRx and HeartStart XL, EFT noise can be misinterpreted as an R-wave. On the HeartStart XL+, EFT noise can disable ECG monitoring, and potentially interrupt demand mode pacing.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All Philips M1783A and M5526A sync cables are affected by this issue. The model number is printed on the outside of the cable, near the end with the ¿ inch phone plug.
- Product
- ECG Out Cable,for use with a Philips ALS monitor/ defibrillator and bedside monitor for Synchronized cardioversion and Transcutaneous pacing.…
- Recalling firm
- Philips Electronics North America Corporation
- Quantity
- 18,604
- Distribution
- Worldwide Distribution - US (nationwide) and to the countries of : Argentina, Australia, Austria, Bahrain, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Ethiopia, Finland, France, Gabon, Germany, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kenya, Republic of Korea, Latvia, Lebanon, Macau, Malaysia, Mexico, Netherlands, New Zealand, Nigeria, Norway, Oman, Philippines, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela and Yemen.
- Recall date
- November 25, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)