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Heart Sync C100-Physio Radiotransparent Defibrillation… recallZ-1434-2013 · Heart Sync, Inc · initiated Apr 26, 2013

Class II Terminated All recalls posted in May 2013

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Heart Sync, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Process design

What the company is doing

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. .

Recall details

Recall number
Z-1434-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Apr 26, 2013
Posted by the FDA
May 30, 2013
Recalling firm
Heart Sync, Inc
Quantity
17180 units for all part numbers
Product code
LDF
FDA submissions
K080421
Distribution
Worldwide Distribution - USA including AL, GA, MI, MN, NC, ND, OH, PA, SD, VA, VT, OH, TX, MA, and Internationally to Korea.

Product description

Heart Sync C100-Physio Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible pacing/ cardioversion Defibrillation /ECG Monitoring electrodes Used in connection with a defibrillator to deliver an electrical current (shock) to the patient's heart during cardiac emergencies.

Code information (models, lots, serial numbers)

Part number : C100-Physio and Lot numbers: Y100112-02, Y102212-03, Y121312-18, Y012413-02, Y022013-01, Y032113-01

Other devices under the same FDA submission

4 devices cleared under K080421 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 65085).

Sources and updates

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