FDA Medical Device Recalls (openFDA)
Picis Inc.: CareSuite" - Critical Care Manager, PACU Manager and Anesthesia Manager Software, transmission & storage, patient data. This product is a non-alarming software patient information system that compiles an electronic medical record utilizing commonly available hardware. A patient record is populated with information from various sources, such as health care professionals, medical devices connected to the system, and data that arrives via hospital and laboratory information systems. The application stores this information in a database and displays it to healthcare providers in different formats for informational purposes. The product is intended for use by healthcare professionals.
- Recall number
- Z-3277-2011
- Recalling firm
- Picis Inc.
- Product
- CareSuite" - Critical Care Manager, PACU Manager and Anesthesia Manager Software, transmission & storage, patient data. This product is a non-alarming software patient information system that compiles an electronic medical record utilizing commonly available hardware. A patient record is populated with information from various sources, such as health care professionals, medical devices connected to the system, and data that arrives via hospital and laboratory information systems. The application stores this information in a database and displays it to healthcare providers in different formats for informational purposes. The product is intended for use by healthcare professionals.
- Status
- Terminated
- Initiated
- 2009-08-12
- Posted
- 2011-09-23
- Terminated
- 2011-09-27
- Reason
- Electronic health record software applications malfunctioned in a manner which failed to display the discontinued status for medication orders, as entered by the attending physician
- Root cause
- Software design
- Action
- Picis Inc. sent a customer notification letter dated August 11, 2009 to all affected customers. The letter describes the product, problem, and action to be taken. Customers informed of the potential patient safety error were advised to make the appropriate configuration change, within current software versions 7.1.4 or later. Contact your local Picis support representative for questions regarding this notice.
- Quantity
- 8576 UNITS
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Australia, Austria, Brussels, Belgium, Denmark, Finland, France, Germany, Malaysia, Netherlands, Norway, Portugal, Singapore, Spain, Sweden, and UK.
- Lot, serial or model codes
- S/W version 7.1 release date - February 2004
- 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