Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm).
This recall has been terminated (originally issued October 13, 2004).
- Company
- Datascope Corp.
- Recall Initiated
- September 24, 2004
- Posted
- October 13, 2004
- Terminated
- September 15, 2005
- Recall Number
- Z-0018-05
- Quantity
- 19
- Firm Location
- Mahwah, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Software anomaly where the variable heart rates may be displayed inaccurately or intermittent 'dashes' may be displayed when the patient's heart rate is derived from ECG.
Distribution
Shipments made to three locations. These are Medstone Internation, Aliso Viejo, CA; Indiana Eye Clinic, Greenwood, IN; and Sumter Urologoly Assoc., Sumter, SC.
Lot / Code Info
Serial Number: MC02017-I3; MC02134-I3; MC02138-I3; MC02148-I3; MC02321-K3; MC02002-I3; MC02005-I3; MC02006-I3; MC02008-I3; MC02020-I3; MC02023-I3; MC02025-I3; MC02027-I3; MC02030-I3; MC02034-I3; MC02043-I3; MC02044-I3; MC02048-I3; MC02052-I3.
Root Cause
Other
Action Taken
Letter was sent on 9/24/2004 via FedEx to the three customers with proof of delivery required.