Heart Sync, Inc.
Medical device manufacturer in Ann Arbor, MI.
5510(k) clearances
0PMA approvals
11recalls
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K131550 | Heart SyncMKJ · Traditional | 12/06/2013SE |
| K131494 | Heart SyncMKJ · Traditional | 09/16/2013SE |
| K120536 | Heart Sync Pediatric Physio AED PadMKJ · Traditional | 08/06/2012SE |
| K081442 | Heart Sync Pediatric, Model PED-100LDD · Traditional | 09/24/2008SE |
| K080421 | Heart Sync, Models C-100 and T-100MKJ · Traditional | 02/29/2008SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0587-2015 Class I | ADULT/CHILD Radiotranslucent Electrode, Part number T100AC-PHILIPS, Rx ONLY, For use…Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED units. The… | 11/11/2014Terminated |
| Z-0586-2015 Class I | ADULT Radiotranslucent Electrode, Part number T100-PHILIPS, Rx ONLY, For use with…Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED units. The… | 11/11/2014Terminated |
| Z-0585-2015 Class I | ADULT Radiotranslucent Electrode, Part number T100LO-PHILIPS, Rx ONLY, For use with…Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED units. The… | 11/11/2014Terminated |
| Z-0584-2015 Class I | ADULT/CHILD Radiotransparent Electrode, Part number C100AC-PHILIPS, Rx ONLY, For use…Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED units. The… | 11/11/2014Terminated |
| Z-0583-2015 Class I | ADULT Radiotransparent Electrode, Part number C100-PHILIPS, Rx ONLY, For use with…Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED units. The… | 11/11/2014Terminated |
| Z-1435-2013 Class II | Vermed, Inc Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible…On 4/18/13 HEARTSYNC became aware of a recall from their wire/connector sub-assembly supplier which is used… | 04/26/2013Terminated |
| Z-1434-2013 Class II | Heart Sync C100-Physio Radiotransparent Defibrillation Electrodes Monophasic or biphasic…On 4/18/13 HEARTSYNC became aware of a recall from their wire/connector sub-assembly supplier which is used… | 04/26/2013Terminated |
| Z-1372-2011 | Medstorm Adult Radiolucent Zoll Medical (Part # 16381, HeartSync, Ann Arbor, MI. The…The seal on the electrode pouch may be open, exposing the electrode to the outside environment. The package… | 12/17/2010Terminated |
| Z-1371-2011 | Medstorm Adult Radiolucent Electrode Philips Medical , Part #16250, HeartSync Ann Arbor…The seal on the electrode pouch may be open, exposing the electrode to the outside environment. The package… | 12/17/2010Terminated |
| Z-1951-2011 | Heart Sync Adult Radiolucent Electrode -Physio Control, Part T100LO-PHYSIO. Indicated…The "leads out" connector had bent pins which would not allow connection to the Medtronic Physio Control… | 12/05/2008Terminated |
| Z-1950-2011 | Medstorm Adult Radiolucent Leads-Out Electrode - Physio-Control, Part 16242. Indicated…The "leads out" connector had bent pins which would not allow connection to the Medtronic Physio Control… | 12/05/2008Terminated |