MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 Product Usage: The HeartStart MRx is for use

FDA device recall Z-0489-2018 · posted 2018-02-08 · Terminated

Recall details

Recalling firm: Philips North America, LLC
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 taken: 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.
Root cause: Nonconforming Material/Component
Status: Terminated
Product code: MKJ
Quantity affected: 71 units
Distribution: No U.S. distribution, Internationally to: India, Ireland, Japan, Republic of Korea, Malaysia, Mexico, South Africa & United Kingdom
Date initiated: 2017-07-12
Date posted: 2018-02-08
Date terminated: 2020-05-27
Location: Andover, MA

Recalls and clearances share one API, with change alerts when new recalls post.

Record	Firm	Date
HEARTSTART MRX MONITOR/DEFIBRILLATOR (K062233)	Philips Medical Systems North America, Inc.	2006-11-22
HEARTSTART MRX, INVASIVE PRESSURE & TEMPERATURE OPTIONS (K061707)	Philips Medical Systems	2006-08-11
HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536A (K051134)	Philips Medical Systems	2005-09-08
HEARTSTART MRX, MODEL M3535A (K040404)	Philips Medical Systems, Inc.	2004-05-04
HEARTSTART MRX, MODEL M3535A (K031187)	Philips Medical Systems	2003-08-27