FDA Device Recall Z-1997-2021: Remote Diagnostic Technologies Ltd. PAVILION C2, ASHWOOD PARK ASHWOOD WAY Basingstoke United Kingdom

Recall Parameters & Description

Normalized public record details for FDA recall code Z-1997-2021.

Recall Res Number

Z-1997-2021

Recalling Firm / Manufacturer

Remote Diagnostic Technologies Ltd. PAVILION C2, ASHWOOD PARK ASHWOOD WAY Basingstoke United Kingdom

FEI Number

3003832357

Recall Status

Open, Classified

Recall Classification

N/A

Date Initiated

2021-05-25

Date Posted

N/A

Date Terminated

N/A

Product Code

MHX

Event Number

88051

Product Quantity

510 systems

Product Description 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).

Reason for Recall The Tempus Pro (Trizeps 7 only) when used in combination with a specified laryngoscope device can cause two error types when subsequently unplugged.

Action Details 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 recommended to reduce the probability of a software reboot during the intervention; - An alternative Video Laryngoscope device may be used to perform any critical interventions such as intubation. - If you are using the Tempus Pro and need to use the Video Laryngoscope on a patient, we recommend completion of any critical interventions before unplugging the Video Laryngoscope from the USB port. - Should the Video Laryngoscope image become frozen on the screen, re-start (turn off and turn back on) the Tempus Pro device. Customer Actions: - Notify all users of the potential risk of loss of monitoring when unplugging the Video Laryngoscope from the Tempus Pro, requiring the device to be restarted. - This issue is limited to specific serial numbers. Please verify that your device is associated with the product included in the scope of this notice utilising attachment 1. - Return your completed Customer Reply form to the email address below, to allow RDT to provide the software update: - Email completed and signed form to: RDT.Recall.Response@Philips.com

Distribution Pattern 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.

Code Information / Serial Numbers Software version number: v07.00, v07.01, v07.18, v07.20, v07.22, v07.24. UDI No. 12NC No. 05060472440020 989706002081 05060472440013 989706000001 05060472441027 989706000051 05060472441058 989706000101

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Medical Device Recall: Z-1997-2021

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer