—#159291

Product

MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 Product Usage: 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 support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician

FDA product code: MKJ — Automated External Defibrillators (Non-Wearable)
Device class: Class 3
Medical specialty: Cardiovascular
510(k) numbers: K031187, K040404, K051134, K061707, K062233
Affected lot / code info: Serial Numbers: US00601802, US00601968, US00601969, US00602114, US00602122, US00602124, US00602125, US00602126, US00602127, US00602128, US00602145, US00602180, US00602182, US00602184, US00602185, US00602186, US00602187, US00602189, US00602206, US00602236, US00602237, US00602238, US00602239, US00602240, US00602241, US00602242, US00602243, US00602244, US00602245, US00602246, US00602247, US00602248, US00602250, US00602251, US00602252, US00602253, US00602254, US00602344, US00602345, US00602346, US00602347, US00602348, US00602349, US00602350, US00602351, US00602352, US00602353, US00602354, US00602355, US00602356, US00602357, US00602358, US00602359, US00602360, US00602361, US00602362, US00602363, US00602364, US00602365, US00602366, US00602367, US00602368, US00602369, US00602370, US00602371, US00602372, US00602373, US00602374, US00602375, US00602376, US00602377

Why it was recalled

Affected units may have a defective component that is intended to protect the internal circuitry from high voltages during shock delivery. The defective component may also prevent delivery of shocks in AED mode.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Philips Healthcare sent an Urgent Medical Device Correction Notification/Field Safety Notice letter dated June, 2017 to their customers. The letter identified the affected product, problem, hazard involved and actions to be taken. Philips is requesting that customers report if their device fails to function as intended. Philips will contact all customers for device replacement once parts are available. If you need further information or support concerning this action, please contact your local Philips representative.

Recalling firm

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

Distribution

Distribution pattern: No U.S. distribution, Internationally to: India, Ireland, Japan, Republic of Korea, Malaysia, Mexico, South Africa & United Kingdom

Timeline

Recall initiated: 2017-07-12
Posted by FDA: 2018-02-08
Terminated: 2020-05-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #159291. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.