Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 25, 2015
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+
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 experience…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Philips Electronics North America Corporation recalled ECG Out Cable,for use with a Philips ALS monitor/ defibrillator and bedside monitor for … - a moderate-severity action.
ECG Out Cable,for use with a Philips ALS monitor/ defibrillator and bedside monitor for … was recalled by Philips Electronics North America Corporation in November 25, 2015. Reason: When a Philips monitor/defibrillator is receiving an ECG signal from an auxiliary bedside monitor via a sync …. Check the official notice for the remedy. Verify recall #Z-0273-2016 with the FDA Devices before acting.
The recall
Philips Electronics North America Corporation issued this moderate-severity FDA Devices recall-When a Philips monitor/defibrillator is receiving an ECG signal from an auxiliary bedside monitor via a sync ….
- Moderate
- severity level
- 19K units
- affected scope
- Class II
- classification
- November 25, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0273-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0273-2016) was formally reported on November 25, 2015, with the manufacturer initiating the action on November 19, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Philips Electronics North America Corporation is listed as the recalling firm, operating out of Andover, MA. Federal records list the affected scope as 18,604.
The documented reason for this recall is: 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 tran… Distribution data in the federal record shows the product reached: 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, F…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
18,604
Related Recalls
6
3 from same agency
Product description
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+
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0273-2016 |
| Date reported | November 25, 2015 |
| Date initiated | November 19, 2014 |
| Recalling firm | Philips Electronics North America Corporation |
| Firm location | Andover, MA |
| Affected scope | 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, German… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0273-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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+. Recalled by Philips Electronics North America Corporation. Units affected: 18,604.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 25, 2015. Severity: Moderate. Recall number: Z-0273-2016.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0273-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 25, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.