Z-0176-06

Spectrum Patient Monitor, Physiological, Patient with arrhythmia detection or alamrs. Monitor can monitor...

Name: Z-0176-06 Spectrum Patient Monitor, Physiological, Patient with arrhythmia detection or alamrs. Monitor can monitor...
Creator: Datascope Corp
Published: 2005-09-07
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2005-09-07 / Terminated / root cause: software

FDA source

Datascope Corp began a recall of Spectrum Patient Monitor, Physiological, Patient with arrhythmia detection or alamrs. Monitor can monitor, display, trend and print a patient''s physiological... on 2005-09-07. The reason FDA records is "Software anomalies which include shut down while printing, invalid diastolic blood pressure display, and incomplete and inaccurate interpretation reports of 12-Lead ECG data". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0176-06
Status: Terminated
Initiated: 2005-09-07
Posted: 2005-11-23
Terminated: 2007-06-06
Recalling firm: Datascope Corp.
Product: Spectrum Patient Monitor, Physiological, Patient with arrhythmia detection or alamrs. Monitor can monitor, display, trend and print a patient''s physiological parameters. The device has a 12.1 inch color display and has a standard configuration of a 3 or 5 lead ECG, Masimo SET SpO2, non-invasive blood pressure, respiration, continuous temperature and IV Drug Calculations. Optional digital displays are provided for invasive blood pressure (up to four) anesthetic agents, O2 and NO2, ST, and CO2.
Product code: DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
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.
Root cause tag: software
FDA root cause: 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: 2318 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.
Product codes and lots: All Spectrum Monitors that have the following Software Versions: A.19, A.20, B.23, B.24, B.25, B.27, C.18, D.07, E.07, F.09, F.16, F.17, F.26.

Product code DRT

K031849Class IISpectrum Patient Monitor, Model 0998-00-0500-XxxxxDatascope Corp. / cleared 2003-09-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)