—#182101

Product

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.

FDA product code: MKJ — Automated External Defibrillators (Non-Wearable)
Device class: Class 3
Medical specialty: Cardiovascular
510(k) numbers: K031187
Affected lot / code info: All devices are affected

Why it 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.

Root cause (FDA determination)

Process control

Action the firm took

On July 16, 2020, the firm distributed an Urgent Medical Device Correction letter to all affected customers. Customers were informed of the product issue and were instructed to do the following: - The MRx is safe to use and can remain in service if the device does not exhibit any of the behaviors described in this Notice (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.) - If an MRx device experiences a switch failure as described, contact your local Philips representative, who can arrange for a replacement of the switch at no charge. - Continue to perform the Shift and Operational Checks described in the Instructions for Use, Maintenance Chapter - To detect possible switch failures as early as possible, conduct Weekly Shock Tests (part of the Shift Check in the IFU) on a daily basis - It is not necessary to perform a Shock Test on days when an Operational Check is performed, since an Operational Check includes a Shock Test. - Keep a copy of the customer letter with each HeartStart MRx Instructions for Use. - To acknowledge receipt of this notification, please complete and fax the Customer Reply Form to the firm. If the MRx Therapy Switch fails, Philips will arrange for the replacement of the switch at no charge to the customer.

Recalling firm

Firm: Philips North America, LLC
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern: Worldwide distribution.

Timeline

Recall initiated: 2020-07-16
Terminated: 2021-08-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #182101. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.