Company:Cybernet Systems Corp
Date of Enforcement Report 3/3/2010
Class:ll
PRODUCT
1) Cybernet Medical MedStar Telemedicine System; Model 533-210. The device is for a remote medical data collection device for the monitoring of patients by healthcare providers. It is intended to work with a weight scale, spirometer, blood pressure unit and pulse oximeter and to transmit data over a phone line. Recall # Z-0852-2010;
2) Cybernet Medical MedStar Telemedicine System; Model 533-380. The device is for a remote medical data collection device for the monitoring of patients by healthcare providers. It is intended to work with a weight scale, spirometer, blood pressure unit and pulse oximeter and to transmit data over a phone line. Recall # Z-0853-2010;
3) Cybernet Medical MedStar Telemedicine System; Model 533-386. The device is for a remote medical data collection device for the monitoring of patients by healthcare providers. It is intended to work with a weight scale, spirometer, blood pressure unit and pulse oximeter and to transmit data over a phone line. Recall # Z-0854-2010;
4) Cybernet Medical MedStar Telemedicine System; Model 533-381. The device is for a remote medical data collection device for the monitoring of patients by healthcare providers. It is intended to work with a weight scale, spirometer, blood pressure unit and pulse oximeter and to transmit data over a phone line. Recall # Z-0855-2010
REASON
A software problem renders these devices incapable of capturing lung function, oxygen saturation and pulse data collected from multiple tests in accordance with the instructions for use.
RECALLING FIRM/MANUFACTURER
Cybernet Systems Corp., Ann Arbor, MI, by letter dated October 27, 2009. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
88 units
DISTRIBUTION
CA, FL, GA, IL, LA, MI, MS, NY, OK, WV
REASON
Demographic data, most notably allergy and precaution data, can be overwritten with incomplete data or blanks by the interface between non-Picis clinical systems (your “HIS” or “CIS”) and certain Picis applications, if that interface is not configured properly.
RECALLING FIRM/MANUFACTURER
Picis Inc., Wakefield, MA, by letter on April 8th 2009. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
325 units
DISTRIBUTION
Nationwide, Australia, Austria, Belgium, Denmark, Finland, France, Germany, Italy, Malaysia, Netherlands, Norway, Portugal, Singapore, Spain, Sweden, and United Kingdom
