| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-00847-1 |
| Product Name/Description |
Philips Efficia CMS200 Central Monitoring Station and the Efficia CM100, CM10, CM120, CM12 and CM150.
Multiple product numbers
ARTG 276813
(Philips Electronics Australia Ltd - Single-patient physiologic monitoring system) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
12/07/2022 |
| Responsible Entity |
|
| Reason/Issue |
Efficia CM100 through CM150 have four software defects in versions C.00, C.01.00 to C.01.02, version 4.0.0.0 and the fourth issue affects all software versions.
Issue 1: When receiving more than one alarm at the same time without a unique identifier, the Central Station only displays the first alarm, even if the second one is of higher priority.
Issue 2: The AUDIO OFF icon might not be presented even if that parameter is in the AUDIO OFF mode.
Issue 3: The AUDIO OFF icon of the temperature parameter is prevented from being displayed properly at the CMS200 Rev. 2.3 when a non-default temperature label is being used.
Issue 4: When there is a failure of the field-programmable gate array component, there can be parameter values which disappear, physiological alarms can stop generating visual or auditory signals, technical alarms may or may not be generated or the monitor can disconnect from the central station. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are advised to institute workarounds as advised in the Customer letter.
Customers will be contacted by a Philips representative to arrange a software upgrade to the latest version which does not have this issue. |
| Contact Information |
Lailah Cheng - 99470171 - Lailah.Cheng@philips.com |