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Picis Perioperative and Critical Care
Picis Clinical Solutions, Inc. · Model 8.6 · UDI-DI 00851831007009
0
510(k) clearances
168
Adverse events (5 deaths)
28
Recalls
7
Facilities
Description
An EMR system used in high acuity areas of the hospital (OR, ICU, Preop, PACU). A patient record is populated with information such as healthcare professionals, medical devices, and HIS/lab systems.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-07-13 | bioMerieux, Inc. | There are 7 reported software anomalies that may affect use of the device. |
| 2017-05-31 | Soft Computer Consultants, Inc. | Display of lab results based on incorrect LOINC code/test descriptions for tests that were performed at a reference lab, saved incorrectly, and sent to systems that display the EMR |
| 2017-01-23 | Merge Healthcare, Inc. | A defect in the software resulted in medications that are not associated with the patient (i.e., medications that the patient is not currently taking) appearing on their report. |
| 2016-10-06 | Soft Computer Consultants, Inc. | Software error. Potential for incorrect results |
| 2016-10-06 | Soft Computer Consultants, Inc. | Software error. Potential for incorrect results |
| 2015-07-29 | BD LIFE SCIENCES | The BD MAX System software version 4.44A contains a software anomaly that has the potential to affect some Open System Reagent (OSR) customers utilizing User Defined Protocol (UDP) |
| 2013-06-21 | Picis Inc. | Notes associated with prescription are not printed to the prescription or to the patient chart. |
| 2013-05-10 | Siemens Healthcare Diagnostics, Inc. | Under certain conditions the system may not perform as intended, causing the release of results to the Laboratory Information System that should have been held for manual review du |
| 2012-07-23 | Cisco Systems Inc | Software anomaly may result in incorrect values and interpretations. The initial vital signs reading will display accurately on the Cisco Health Presence Vitals tab and the OnePlac |
| 2012-07-16 | Roche Molecular Systems, Inc. | Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.