FDA Medical Device Recalls (openFDA)
Witt Biomedical Corporation: Product is a CALYSTO Series IV Physio-monitoring & Information System model # M-S0053.
- Recall number
- Z-0305-06
- Recalling firm
- Witt Biomedical Corporation
- Product
- Product is a CALYSTO Series IV Physio-monitoring & Information System model # M-S0053.
- Status
- Terminated
- Initiated
- 2005-09-16
- Posted
- 2005-12-23
- Terminated
- 2012-07-11
- Reason
- Customer complained that a boom monitor came off the boom. No patient or user injury was associated with the incident.
- Root cause
- Other
- Action
- Consignees will be notified of recall by phone, the firm will use a phone script.
- Quantity
- 1541
- Distribution
- Products were distributed to approximately 672 medical facilities throughout the United States.
- Lot, serial or model codes
- Serial numbers 970424D to 200501499.
- 510(k) numbers
- ["K033030"]
- PMA numbers
- not on file
- Product code
- MWI
- Firm FEI
- 1051786
- Firm city
- Melbourne
- Firm state
- FL
- 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