seca analytics 115
seca GmbH & Co. KG · Model 115 · UDI-DI 04012030013383
Description
The seca 115 PC software is for administering weight, height, bioimpedance and vital measurements and for calculating automatically parameters such as FMI (fat mass index) which can be derived from these measurements. Results are displayed in graphical form and provide support with the following medical issues: • Documentation of weight changes • Documentation of energy expenditure and energy reserves • Documentation of cardiometabolic risk • Documentation of metabolic activity and the success of a training program, e.g. within the framework of rehabilitation or physiotherapy • Documentation of a patient’s fluids status and documentation of changes in fluids • Documentation of changes in vital signs
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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