Zoll Auto Pulse Resuscitation System; Zoll Circulation Inc., Sunnyvale, CA 94085 Cardiac Compressor used as an adjunct t
FDA device recall Z-1904-2011 · posted 2011-04-07 · Terminated
Recall details
- Recalling firm
- Zoll Circulation, Inc.
- Reason for recall
- Complaints of batteries discharging prematurely and that during use the Auto Pulse Units would cease operating (providing compressions).
- Action taken
- The firm, Zoll Circulation Inc., initiated a Corrective and Preventive Action Report on January 28, 2009. According to the firm, the customers were contacted by telephone calls and were provided with a Battery Maintenance program. For further questions you may call (408) 541-2140 ext.341.
- Root cause
- Other
- Status
- Terminated
- Product code
- DRM
- Quantity affected
- not provided
- Distribution
- Nationwide Distribution -- including, VA, NY, OH, IN, MO, UT, FL, NC, ME, WA, SD, NM, PA, MS, ID, TX, GA, CA, CO, IL, AR, WV, TN, OR, and KS.
- Date initiated
- 2008-01-28
- Date posted
- 2011-04-07
- Date terminated
- 2011-04-28
- Location
- Sunnyvale, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AUTOPULSE RESUSCITATION SYSTEM, MODEL 100 (K072527) | Zoll Circulation | 2008-03-19 |