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. Subjects screened for sleep apnea should have periods of sleep of at least 4 hours duration during which the ECG is predominantly sinus rhythm in nature.
FDA Recall Z-0520-2012 · Posted 2012-01-11
Recalling FirmDel Mar Reynolds Medical, Ltd.
Recall StatusTerminated
Product CodeMNR
Date Initiated2011-11-11
Date Terminated2012-06-05
Product Quantitytotal 523 units and 171 kits (34 units and 7 kits in US; 489 units and 164 kits outside US)
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
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, HUNGARY, INDIA, ISRAEL, ITALY, KUWAIT, MALTA, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, POLAND, PORTUGAL, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, Slovakia, SPAIN, SWEDEN, SWITZERLAND, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.