Recall record at a glance
| Official record | Z-2794-2020 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Philips North America, LLC |
| Report date | Aug 19, 2020 |
| Recall initiation date | Jul 16, 2020 |
| Quantity | 95,212 units |
| Location | Andover, MA, United States |
Official product description
Philips HeartStart MRx, Monitor/Defibrillators with model numbers M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9 - Product Usage: is intended for use in hospital and pre-hospital settings by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support or defibrillation.
Why the product was recalled
The therapy switch may fail, resulting in the device exhibiting the following behaviors: the device may not perform the selected function, the therapy knob may not change to the energy setting selected, or the device may deliver a shock with an energy level different from the setting selected by the user. These device behaviors could result in a delay in therapy or a failure to deliver the intended therapy.
Distribution information
Worldwide distribution.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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