Recall Z-0520-2012 ยท MNR Ventilatory Effort Recorder
Del Mar Reynolds Medical, Ltd.
Lifescreen Apnea is Lifescreen ECG Screening System, Version 3.31. Lifescreen Apnea is indicated for screening adults for the probability that they suffer from obstructive sleep apnea, mixed apnea or hypopnea, in order to evaluate the necessity for a polysomonographic examination. The ECG recording may be obtained at any location specified by a physician including home, hospital or clinic. Subj
| Date | Jan 11, 2012 (initiated Nov 11, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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 |
| Quantity | 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, CHINA, COLOMBIA, COSTA RICA, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HONDURAS, HONG KONG, HUNG |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042745 | LIFESCREEN APNEA Del Mar Reynolds Medical, Inc., Jan 19, 2005 |