Recall Z-3160-2011 ยท NSX
Picis Inc.
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 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 th
| Date | Sep 7, 2011 (initiated Aug 1, 2011) |
| Status | Terminated |
| Reason | Software does not display appropriate allergy interaction warning |
| Root cause | Software design |
| Action | Picis issued notification on 08/01/11 to affected clients, explaining the potential for the error, with instructions to monitor documented patient allergies closely when prescribing medication orders in ED PulseCheck, using Muitum drug database content. Picis will track the progress on acknowledgement of notification letter receipt through the implementation of software upgrade, for all potentially affected Customers. For questions regarding this recall call 781-557-3000. |
| Quantity | 62 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.