Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs). Product Usage: The models M5066A, M50

FDA device recall Z-1232-2014 · posted 2014-03-19 · Terminated

Recall details

Recalling firm

Philips Medical Systems North America Inc.

Reason for recall

Philips is recalling HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs) because one or both contact pins may be contaminated by residue from the soldering process. This contamination could prevent an adequate connection between the pads cartridge and the AED. If poor contact between the pads cartridge and AED occurs, the device may be unable to deliver therapy in an emergency.

Action taken

Philips began sending out the Urgent Medical Device Recall HeartStart Home and OnSite (HS1) letter, dated 2014 FEB 10, to consignees on 2/17/14. The letter identified the product, the problem, and the action to be taken by the customer. Customers are advised to contact Philips for a replacement AED at 1-800-263-3342 and select option 5. Live technical support is available Monday through Friday, 7:00AM to 5:00PM PST. Customers can also leave a message 24 hours a day, seven days a week. DISTRIBUTORS are instructed to provide Philips with the information provided in the letter. Customers who have an affected device will be supplied with a replacement AED from Philips, free of charge. If customers/distributors need any further information or support concerning this issue, please visit www.philips.com/HeartStartHS1PinAction.

Root cause

Vendor change control

Status

Terminated

Product code

MKJ

Quantity affected

5075 units total (2724 units in the US and 2351 units outside the US)

Distribution

Worldwide Distribution - USA Nationwide

Date initiated

2014-02-06

Date posted

2014-03-19

Date terminated

2017-03-23

Location

Bothell, WA

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