Data / Medical devices / United States / Picis Clinical Solutions, Inc.
Picis Clinical Solutions, Inc.: FDA-registered device maker in Peabody, MA, United States, 1 510(k) clearance
Picis Clinical Solutions, Inc. is registered with the FDA (registration 3005244943) in Peabody, MA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated August 27, 2012. 6 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005244943
- Address
- 9 Centennial Drive Suite 202, Peabody, MA, United States, 01960
- Owner or operator
- Picis Clinical Solutions, Inc. (9076483)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- January 4, 2013
- Registered through
- 2026
- Brand names listed
- Picis Perioperative and Critical Care
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Calculator, Drug Dose | NDC | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 27, 2012 | K121542 | PICIS WEIGHT BASED DOSE CONVERTER | NDC | Substantially Equivalent | Picis, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 21, 2013 | 65666 | Class II | Terminated | Picis ED Pulsecheck - EMR Software Application - 2125, Software Versions: 5.2 and 5.3. The application stores patient information in a database, and it may analyze and/or display the data in different formats for evaluat | Notes associated with prescription are not printed to the prescription or to the patient chart. | accessdata.fda.gov |
| August 12, 2011 | 60006 | Not yet classified | Terminated | Picis Anesthesia Manager, PACU Manager,Critical Care Manager-8.2 Service Pack 4 or higher (Software, transmission & storage, patient data) This product is a non-alarming software patient information system that compiles | Periop/Critical Care Manager EHR Software Application displayed one patient's demographic and health information in place of another patient that was in current view. | accessdata.fda.gov |
| August 1, 2011 | 59737 | Not yet classified | Terminated | Picis ED PulseCheck-Software, transmission & storage, patient data Service Pack v5.0 L and M This product is a non-alarming software patient information system that compiles an electronic medical record utilizing commonl | Software does not display appropriate allergy interaction warning | accessdata.fda.gov |
| March 8, 2010 | 54934 | Not yet classified | Terminated | CareSuite" - Critical Care Manager, PACU Manager and Anesthesia Manager Software: CareSuite 5.1 and later | 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. | accessdata.fda.gov |
| August 12, 2009 | 53897 | Not yet classified | Terminated | 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 medic | 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 | accessdata.fda.gov |
| April 8, 2009 | 51876 | Not yet classified | Terminated | PICIS, CareSuite Family- OR Manager (4235), Preop Manager (4250), Anesthesia Manager (4220), PACU Manager (4245) & Critical Care Manager (1110), patient information systems. | 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. | accessdata.fda.gov |
Compare with other makers
Updated July 29, 2013. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.