Picis
Country not established
- Devices
- 2
- FDA recalls
- 6
At a glance
Market reach
- United States
- FDA recalls
What Picis makes
Picis produces electronic medical record and clinical documentation systems designed for use in perioperative and emergency care settings, including the PICIS CHART+ platform. This software integrates patient data, anesthesia records, and surgical documentation to support workflow efficiency in operating rooms and trauma centers.
The company’s products are classified as Class II medical devices under FDA regulations and are authorised through the 510(k) clearance process. These systems are listed in the FDA’s 510(k) database, adhering to US regulatory standards for software-as-a-medical-device applications in clinical environments.
Catalogue
Picis Weight Based Dose Converter Ref K121542
Regimes: 510(k) Registry: 510(k)Picis Chart+ Ref K950536
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 6 recalls initiated by Picis, the earliest on 2009-04-08 and the most recent on 2013-06-21. By recorded status: 6 terminated. The reasons filed fall into these groups: labeling or instructions for use and software or firmware. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2013
- 21 Jun 2013 Z-1814-2013 Class II Terminated Notes associated with prescription are not printed to the prescription or to the patient chart.
Full distribution text
- 21 Jun 2013 Z-1814-2013 Class II Terminated Notes associated with prescription are not printed to the prescription or to the patient chart.
2011
- 12 Aug 2011 Z-0139-2012 Unclassified (pre-2012) Terminated 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.
- 1 Aug 2011 Z-3160-2011 Unclassified (pre-2012) Terminated Software does not display appropriate allergy interaction warning
2010
- 8 Mar 2010 Z-1252-2010 Unclassified (pre-2012) Terminated 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
2009
- 12 Aug 2009 Z-3277-2011 Unclassified (pre-2012) Terminated 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
Full distribution text
- 8 Apr 2009 Z-0365-2010 Unclassified (pre-2012) Terminated 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.
Full distribution text
- 12 Aug 2009 Z-3277-2011 Unclassified (pre-2012) Terminated 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
Frequently asked questions
How many devices does Picis have in the registry?
The registry currently lists 2 devices for Picis. Devices recorded under merged duplicate company entries are counted once.
Which registries list Picis's devices?
Among its 2 most recently registered devices, Picis has devices listed in FDA 510(k) (2 devices).
What risk classes do Picis's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Picis's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Picis?
FDA recall records list 6 recalls initiated by Picis, the most recent initiated on 21 Jun 2013. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Picis in the registry?
The most recently registered devices listed for Picis include PICIS WEIGHT BASED DOSE CONVERTER and PICIS CHART+.