Food, drugs, devices › Philips North America, LLC
Device recall: HeartStart XL+ Defibrillator/Monitor, Model 861290
Philips North America, LLC (Andover, MA) initiated this device recall on 16 Oct 2019; FDA lists 1 product record under event 84115, 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 968 device enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 29 Nov 2023. Initiation: voluntary: firm initiated. Philips North America, LLC has 129 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 North America, LLC, Andover, MA.
Reason for recall
"The rotary therapy selector switch may fail, resulting in unexpected device behavior. These behaviors include: The device may not turn on; The device may not perform the selected function; The device may deliver a shock with an energy level different from the setting selected by the user."
Distribution
"US Nationwide"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0498-2020 | HeartStart XL+ Defibrillator/Monitor, Model 861290 | 23,749 Units | Class II | Terminated | 27 Nov 2019 |
Context
Other enforcement events for Philips North America, LLC
All 129 events for Philips North America, LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The rotary therapy selector switch may fail, resulting in unexpected device behavior. These behaviors include: The device may not turn on; The device may not perform the selected function; The device may deliver a shock with an energy level different from the setting selected by the user."
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: "US Nationwide"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 29 Nov 2023. "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.