Datascope Corp 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) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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)
Brand
Datascope Corp
Lot Codes / Batch Numbers
Passport 2 Monitors with software versions: S.10, T.15, T.31, V.07, W.09, W.13, W.14.
Products Sold
Passport 2 Monitors with software versions: S.10, T.15, T.31, V.07, W.09, W.13, W.14.
Datascope Corp is recalling Passport 2 with View 12 ECG Analysis Module. It is a transportable, multi-parameter physiological m due to Software anomalies which include shut down while printing, invalid diastolic blood pressure display, and incomplete and inaccurate interpretation repo. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software anomalies which include shut down while printing, invalid diastolic blood pressure display, and incomplete and inaccurate interpretation reports of 12-Lead ECG data.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, IL, NY, VA
Page updated: Jan 10, 2026