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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm September 07, 2005
Date Posted November 23, 2005
Recall Status1 Terminated 3 on June 06, 2007
Recall Number Z-0177-06
Recall Event ID 33724
510(K)Number K020550  
Product Classification Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) - Product Code DRT
Product Passport 2 with View 12 ECG Analysis Module. It is a transportable, multi-parameter physiological monitor designed to monitor and display the following physiological parameters: ECG, Heart Rate derived from selected sources (Sp)2, ECG, IBP and NIBP), SpO2 level, ST Segment, Arrhythmia, Blood pressure (both invasive and non-invasive), Respiration rate (dirived from ECG or CO2), inspired or expired CO2, temperature , and gases (i.e. five anesthetsia gases, O2, N2O, and CO2)
Code Information Passport 2 Monitors with software versions: S.10, T.15, T.31, V.07, W.09, W.13, W.14.
Recalling Firm/
Manufacturer		 Datascope Corp
800 MacArthur Blvd
Mahwah NJ 07430-2001
For Additional Information Contact Susan E. Mandy
201-995-8025
Manufacturer Reason
for Recall		 Software anomalies which include shut down while printing, invalid diastolic blood pressure display, and incomplete and inaccurate interpretation reports of 12-Lead ECG data.
FDA Determined
Cause 2		 Other
Action Datascope sent out a Field Correction notice on 9/7/2005 to all Hospital administrators who have the monitors. This was sent out via certified mail, return receipt requested. A Datascope Service Rep will conduct and document the corrective action during a visit to the customer.
Quantity in Commerce 979 monitors
Distribution The monitors have been distributed domestically and internationally to hospitals and clinics. There are 10 Passport 2 monitors distributed to Naval Hospital, Camp Pendleton, CA. There are 12 Spectrum monitors distributed to two US Govt facilities: VA Medical Center, Hines, IL and VA Medical Center, Syracuse, NY.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DRT and Original Applicant = DATASCOPE CORP.
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