Recall Z-1997-2021 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Remote Diagnostic Technologies Ltd.
Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm. Part No. - 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. Product Usage: intended to be used as a stand-alone monitor or as a telemedicine system (transmitting patient data to other medical professionals located elsewhere).
| Date | May 25, 2021 |
| Status | Open, Classified |
| Reason | The Tempus Pro (Trizeps 7 only) when used in combination with a specified laryngoscope device can cause two error types when subsequently unplugged. |
| Root cause | Software design |
| Action | On June 2, 2021, Philips issued an Urgent Medical Device Correction notice to customers via letter and email notifying them an intermittent software error has been detected as a part of an internal production control activity. The error can occur immediately after unplugging the Video Laryngoscope from the USB port. If the customer identifies affected products in use or in inventory: Clinical User Actions: - Users of Tempus Pro who are not using a Video Laryngoscope do not need to take any further actions. - When a Video Laryngoscope is required to be used, the following actions are recommen |
| Quantity | 510 systems |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of FL, TX, PA, MN, UT, MT, CA, WI, VA, NY, TN, KS, MD and the countries of Australia, Austria, Czech Republic, France, Germany, Hong Kong, Israel, Italy, Netherlands, Thailand, Abu Dhabi, UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201746 | Tempus Pro Patient Monitor Remote Diagnostic Technologies Limited, Sep 18, 2020 |