Food, drugs, devices › Philips Healthcare Inc.
Device recall: Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 The Heartstart MRx is for use for the terminat
Philips Healthcare Inc. (Andover, MA) initiated this device recall on 20 Jun 2012; FDA lists 1 product record under event 62342, classified Class II.
FDA defines Class II as 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. 88% of the 823 device enforcement events initiated in 2012 carry the same class.
Status: Terminated, terminated 14 Aug 2013. Initiation: voluntary: firm initiated. Philips Healthcare Inc. has 34 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Philips Healthcare Inc., Andover, MA.
Reason for recall
"Defibrillator/monitor cannot analyze an ECG report during acquisition of 12 lead ECG"
Distribution
"Worldwide Distribution - USA including FL, IN, MA, M, NY, OH, TN, TX, and VA. Internationally to AUSTRALIA, HONG KONG, and INDIA"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1986-2012 | Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 The Heartstart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life… | 35 units | Class II | Terminated | 18 Jul 2012 |
Context
Other enforcement events for Philips Healthcare Inc.
All 34 events for Philips Healthcare Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Defibrillator/monitor cannot analyze an ECG report during acquisition of 12 lead ECG"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - USA including FL, IN, MA, M, NY, OH, TN, TX, and VA. Internationally to AUSTRALIA, HONG KONG, and INDIA"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 14 Aug 2013. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.