Heart Sync Adult Radiolucent Electrode -Physio Control, Part T100LO-PHYSIO. Indicated for use in external pacing, defibr
FDA device recall Z-1951-2011 · posted 2011-04-12 · Terminated
Recall details
- Recalling firm
- Heart Sync, Inc
- Reason for recall
- The "leads out" connector had bent pins which would not allow connection to the Medtronic Physio Control Defibrillator cable during a product demonstration.
- Action taken
- The firm sent a recall notice to their distributors on 12/3/2008 asking them to quarantine product and return it to HeartSync. The letter stated that customers' current inventory would be exchanged for new product. Customers were to call 1-800-828-4681 to provide the necessary information.
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- MLN
- Quantity affected
- 50 (5 cases of 10 each)
- Distribution
- Nationwide Distribution
- Date initiated
- 2008-12-05
- Date posted
- 2011-04-12
- Date terminated
- 2011-04-13
- Location
- Ann Arbor, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEART SYNC, MODELS C-100 AND T-100 (K080421) | Heart Sync, LLC | 2008-02-29 |