Heart Sync, Inc.
Heart Sync, Inc. appears in FDA public data with 7 recalls — including 5 Class I (most serious) —, 5 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0587-2015, Class I) was initiated on November 11, 2014. Its most recent 510(k) clearance was granted on December 6, 2013.
Summary
- Total Recalls
- 7 (5 Class I)
- 510(k) Clearances
- 5
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0587-2015 | Class I | ADULT/CHILD Radiotranslucent Electrode, Part number T100AC-PHILIPS, Rx ONLY, For use with Philips He | November 11, 2014 |
| Z-0583-2015 | Class I | ADULT Radiotransparent Electrode, Part number C100-PHILIPS, Rx ONLY, For use with Philips HeartStart | November 11, 2014 |
| Z-0584-2015 | Class I | ADULT/CHILD Radiotransparent Electrode, Part number C100AC-PHILIPS, Rx ONLY, For use with Philips He | November 11, 2014 |
| Z-0586-2015 | Class I | ADULT Radiotranslucent Electrode, Part number T100-PHILIPS, Rx ONLY, For use with Philips HeartStart | November 11, 2014 |
| Z-0585-2015 | Class I | ADULT Radiotranslucent Electrode, Part number T100LO-PHILIPS, Rx ONLY, For use with Philips HeartSta | November 11, 2014 |
| Z-1434-2013 | Class II | Heart Sync C100-Physio Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible | April 26, 2013 |
| Z-1435-2013 | Class II | Vermed, Inc Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible defibrilla | April 26, 2013 |