FDA Medical Device Recalls (openFDA)
Picis Inc.: PICIS, CareSuite Family- OR Manager (4235), Preop Manager (4250), Anesthesia Manager (4220), PACU Manager (4245) & Critical Care Manager (1110), patient information systems.
- Recall number
- Z-0365-2010
- Recalling firm
- Picis Inc.
- Product
- PICIS, CareSuite Family- OR Manager (4235), Preop Manager (4250), Anesthesia Manager (4220), PACU Manager (4245) & Critical Care Manager (1110), patient information systems.
- Status
- Terminated
- Initiated
- 2009-04-08
- Posted
- 2009-11-18
- Terminated
- 2014-12-22
- Reason
- Demographic data, most notably allergy and precaution data, can be overwritten with incomplete data or blanks by the interface between non-Picis clinical systems (your "HIS" or "CIS") and certain Picis applications, if that interface is not configured properly.
- Root cause
- Software design
- Action
- On April 8th 2009, Picis initiated a customer notification letter to the installed base of potentially affected users, explaining the potential source of patient data conflict and to provide support in choosing the appropriate configuration option and implementation. The notification letters included with this report package contain additional details regarding configuration options.
- Quantity
- 325
- Distribution
- Worldwide distribution: USA, Australia, Austria, Belgium, Denmark, Finland, France, Germany, Italy, Malaysia, Netherlands, Norway, Portugal, Singapore, Spain, Sweden, and United Kingdom
- Lot, serial or model codes
- Software version 7.2.2
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NSX
- Firm FEI
- 3005244943
- Firm city
- Wakefield
- Firm state
- MA
- 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