FDA Medical Device Recalls (openFDA)
Datascope Corp: Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm).
- Recall number
- Z-0018-05
- Recalling firm
- Datascope Corp
- Product
- Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm).
- Status
- Terminated
- Initiated
- 2004-09-24
- Posted
- 2004-10-13
- Terminated
- 2005-09-15
- Reason
- 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.
- Root cause
- Other
- Action
- Letter was sent on 9/24/2004 via FedEx to the three customers with proof of delivery required.
- Quantity
- 19
- 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, serial or model codes
- 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.
- 510(k) numbers
- ["K032338"]
- PMA numbers
- not on file
- Product code
- NWI
- Firm FEI
- 2221819
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28