FDA Medical Device Recalls (openFDA)
Datascope Corp: Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm).
- Recall number
- Z-1483-04
- Recalling firm
- Datascope Corp
- Product
- Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm).
- Status
- Terminated
- Initiated
- 2004-07-28
- Posted
- 2004-09-21
- Terminated
- 2004-11-22
- Reason
- The Trio Monitor has latex feet. It is not labeled per 21 CFR801.437 to indicate that it contains latex.
- Root cause
- Other
- Action
- On July 28, 2004, the firm sent out a Urgent Product Field Correction via FedEx to their customers. Enclosed with this letter was the replacement feet, an Instruction form and a field correction completion form.
- Quantity
- 146
- Distribution
- Product was shipped to hospitals and medical clinics nationwide.
- Lot, serial or model codes
- Serial Numbers: MC01475-D3; MC02325-K3; MC01476-D3; MC02120-I3; MC02017-I3; MC02004-I3; MC02011-I3; MC02018-I3; MC02047-I3; MC02039-I3; MC02196-I3; MC02279-K3; MC02295-K3; MC02298-K3; MC01478-D3; MC01491-D3; MC01496-D3; MC01865-G3; MC01455-D3; MC02281-K3; MC02237-I3; MC05179-C4; MC05180-C4; MC05191-C4; MC05194-C4; MC05206-C4; MC05218-C4; MC05223-C4; MC01497-D3; MC01452-D3; MC01473-D3; MC01490-D3; MC01493-D3; MC01861-G3; MC02354-K3; MC02293-K3; MC02303-K3; MC02316-K3; MC02134-I3; MC02138-I3; MC02148-I3; MC02321-K3; MC02292-K3; MC01487-D3; MC02285-K3; MC02309-K3; MC02313-K3; MC05082-C4; MC05107-C4; MC02306-K3; MC01862-G3; MC01918-H3; MC01479-D3; MC05183-C4; MC05189-C4; MC01474-D3; MC01477-D3; MC01450-D3; MC05072-C4; MC05075-C4; MC05083-C4; MC05089-C4; MC05090-C4; MC05105-C4; MC05178-C4; MC05195-C4; MC05209-C4; MC05210-C4; MC05212-C4; MC05213-C4; MC05214-C4; MC05215-C4; MC05217-C4; MC05224-C4; MC01448-D3; MC01449-D3; MC01464-D3; MC01481-D3; MC01495-D3; MC01859-G3; MC01867-G3; MC01890-H3; MC02348-K3; MC02359-K3; MC02363-K3; MC01453-D3; MC01860-G3; MC02199-I3; MC01460-D3; MC01806-G3; MC01954-H3; MC02135-I3; MC02136-I3; MC02146-I3; MC02168-I3; MC02171-I3; MC02278-K3; MC02280-K3; MC05172-C4; MC05173-C4; MC05174-C4; MC05181-C4; MC05184-C4; MC05188-C4; MC05190-C4; MC05201-C4; MC05203-C4; MC05208-C4; MC05219-C4; MC05222-C4; MC05225-C4; MC05227-C4; 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; MC05182-C4; MC05185-C4; MC05192-C4; MC05199-C4; MC01869-G3; MC02326-K3; MC02344-K3; MC02357-K3; MC02365-K3; MC01866-G3; MC01868-G3; MC01929-H3; MC01949-H3; MC02187-I3; MC02277-K3; MC01482-D3; MC01488-D3; MC02177-I3; MC02290-K3; MC02317-K3.
- 510(k) numbers
- ["K032338"]
- PMA numbers
- not on file
- Product code
- DRT
- 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