Lifescreen Apnea is Lifescreen ECG Screening System, Version 3.31. Lifescreen Apnea is indicated for screening adults fo
FDA device recall Z-0520-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Del Mar Reynolds Medical, Ltd.
- Reason for recall
- When Lifescreen is left open and a new recording is loaded from Sentinel Cardiology Information Management System, customers can get corruption in the data or a wrong ECG after the first 32 hours. Both recordings have to be longer than 32 hours for this to happen.
- Action taken
- Spacelabs Healthcare sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated November 11, 2011 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. Customers are advised to close Lifescreen every time before loading another recording from the Sentinel database. Spacelabs is in the process of upgrading software and will contact customers to arrange for an update to affected systems. If you have any questions about this corrective action program, please contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MNR
- Quantity affected
- total 523 units and 171 kits (34 units and 7 kits in US; 489 units and 164 kits outside US)
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of AR, CA, CO, CT, FL, GA, KY, LA, MA, MD, MI, MN, NC, NY, OH, TN, TX, UT, WV, and PUERTO RICO and the countries of AUSTRIA, BELGIUM, CHILE
- Date initiated
- 2011-11-11
- Date posted
- 2012-01-11
- Date terminated
- 2012-06-05
- Location
- Hertford, United Kingdom
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIFESCREEN APNEA (K042745) | Del Mar Reynolds Medical, Inc. | 2005-01-19 |