FDA Device Recall Z-0489-2018: Philips North America, LLC

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0489-2018.

Recall Res Number

Z-0489-2018

Recalling Firm / Manufacturer

Philips North America, LLC

FEI Number

1218950

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2017-07-12

Date Posted

2018-02-08

Date Terminated

2020-05-27

Product Code

MKJ

Event Number

78351

Product Quantity

71 units

Product Description 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

Reason for Recall 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.

Action Details 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.

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

Code Information / Serial Numbers 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

Related Establishments / Registrations

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Medical Device Recall: Z-0489-2018

Recall Parameters & Description

Related Establishments / Registrations

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