Safety Notice for External Pulse Generators PACE 203H, PACE 300 and Model 3085, Osypka Medical GmbH
2010.08.25
Product group Medical electronics / Electromedical devices
Reference 02185/10
Osypka Medical GmbH has issued a Field Safety Notice concerning a corrective action of the External Pulse Generators PACE 203H, PACE 300 and Model 3085 in the range from serial number 0706101 to serial number 1001210. A potential incompatibility of new 9 V batteries which showed a high Open Circuit Voltage (OCV) could cause a stop of stimulation. Until the update is completed the affected pulse generators should only be run by a battery with an OCV not higher than 9.2 V.