M3536A HeartStart MRx with Wireless Link Upgrade (861289) The HeartStart MRx is for use for the termination of ventricul
FDA device recall Z-1108-2014 · posted 2014-02-26 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems, Inc.
- Reason for recall
- Wireless Link may be unable to transmit data when configured for a specific data flow.
- Action taken
- Philips Healthcare sent an Urgent Medical Device Correction letter to all consignees on February 18, 2014. The Letter informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. Philips is initiating a correction to affected devices. Philips will release a new version of Wireless Link software V2.0.0.3 sub1 that corrects the issue. The correction will be provided free of charge to all units affected by this issue. A Philips Healthcare representative will contact customers with affected devices to arrange for installation of the software upgrade. Customers with questons were instructed to call 1-800-722-9377. For questions regarding this recall call 800-722-9377.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 220 devices
- Distribution
- Worldwide Distribution - USA including AZ, CA, FL, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NY, OH, OK, OR, PA, SC, TN, TX,and VA and Internationally to Australia, Norway, and Spain.
- Date initiated
- 2014-02-18
- Date posted
- 2014-02-26
- Date terminated
- 2015-11-12
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536A (K051134) | Philips Medical Systems | 2005-09-08 |