ECG Out Cable — Class II medical device recall Z-0273-2016
Terminated recall by Philips Electronics North America Corporation, reported 2015-11-25, distributed nationwide. When a Philips monitor/defibrillator is receiving an ECG signal from an auxiliary bedside monitor via a sync c
| Recall number | Z-0273-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Electronics North America Corporation, Andover, MA, United States |
| Recall initiated | 2014-11-19 |
| Classified | 2015-11-13 |
| Reported by FDA | 2015-11-25 |
| Terminated | 2017-09-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BH, BO, BR, CA, CH, CL, CN, CO, CY, CZ, DE, ES, FI, FR, GB, HK, HU, ID, IE, IL, IN, IS, IT, JP, KE, KR, LB, LK, LV, MX, MY, NG, NL, NO, NZ, OM, PH, PL, PT, QA, SA, SE, SG, TH, TR, TW, UA, VE, ZA |
| Quantity | 18,604 |
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+
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0273-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.