Heart Sync C100-Physio Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible pacing/ cardioversio

FDA device recall Z-1434-2013 · posted 2013-05-30 · Terminated

Recall details

Recalling firm

Heart Sync, Inc

Reason for recall

On 4/18/13 HEARTSYNC became aware of a recall from their wire/connector sub-assembly supplier which is used in the C100-Physio Electrodes. There were reports of equipment damage due to misalignment from tooling installed in August 2012. The result of this damage could render the device incapable of delivering the appropriate energy or shock to the patient.

Action taken

HeartSync sent an URGENT MEDICAL DEVICE RECALL notification letter dated April 26, 2013, to all consignees of Heart Sync for C100-Physio Radiotransparent Defrillation Electrodes. On April 29, 2013, an URGENT MEDICAL DEVICE RECALL notification was sent to Vermed Inc for the D304 Defrillation Electrodes . The letters identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return the affected product to the firm for full credit. Customers were asked to complete the form and send back via fax to 734-213-5640 or call 734-213-5530. For questions regarding this recall call 734-213-5530. .

Root cause

Process design

Status

Terminated

Product code

LDF

Quantity affected

17180 units for all part numbers

Distribution

Worldwide Distribution - USA including AL, GA, MI, MN, NC, ND, OH, PA, SD, VA, VT, OH, TX, MA, and Internationally to Korea.

Date initiated

2013-04-26

Date posted

2013-05-30

Date terminated

2014-04-16

Location

Ann Arbor, MI

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