FDA Medical Device Recalls (openFDA)
Picis Inc.: CareSuite" - Critical Care Manager, PACU Manager and Anesthesia Manager Software: CareSuite 5.1 and later
- Recall number
- Z-1252-2010
- Recalling firm
- Picis Inc.
- Product
- CareSuite" - Critical Care Manager, PACU Manager and Anesthesia Manager Software: CareSuite 5.1 and later
- Status
- Terminated
- Initiated
- 2010-03-08
- Posted
- 2010-04-06
- Terminated
- 2013-07-01
- Reason
- Under specific timing of conditions and in configuration with 3rd party infusion pumps, an error within the clinical application causes the manual documentation of clinical orders to be changed to an automatic update status. At this point, the order documentation becomes frozen at the last dose and/or rate and the user is unable to modify, stop or delete it. This error could impact the fluid bala
- Root cause
- Software design
- Action
- Picis issued letter notification beginning on March 8, 2010 with software correction information. The letter communicates details of the problem, along with recommendations for mitigating the potential to experience this error condition. Use of the product should be discontinued until the update described in the letter is performed. Customers with questions should call the company at 781-557-3000.
- Quantity
- 23
- Distribution
- NJ Canada, Australia, Austria,Denmark, Finland, Germany Norway,Portugal, Sweden, France,Netherlands, Spain.
- Lot, serial or model codes
- Software version CareSuite 5.1 and later.
- 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