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Tempus Pro recallZ-2625-2023 · Remote Diagnostic Technologies Ltd. · initiated Aug 24, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Remote Diagnostic Technologies Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Full screen error message may occur on patient monitors with affected hardware version, either during or after laryngoscopes are unplugged from monitors, informing users a 60-100 second shutdown/restart are required. Error prevents: viewing graphical patient vital signs, sounding of pulse audio tone, visualization of patient airway used during intubation; may lead to treatment delay or hypoxia.

FDA root cause category: Device Design

What the company is doing

On 8/24/23 Correction Notices were mailed to customers and distributors who were asked to do the following: 1) If monitor has Trizeps-7 Hardware, remove the laryngoscope from service with this monitor. Users must use an alternative laryngoscope not connected to the Tempus Pro Monitor to manage the patient s airway to avoid interruption in patient care. The Tempus Pro Monitor can remain in service if the Tempus Pro Video Laryngoscope is not connected to the monitor. 2) If monitor has Trizeps-6 Hardware, the laryngoscope can continue to be used with the monitor. 3) Post this Urgent Medical Device Correction letter on or near the affected device. 4) Pass this notice on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred (if appropriate). 5) Complete and return the Urgent Medical Device Correction response form. Distributors were asked to take the following additional actions: If you have any Tempus Pro Video Laryngoscopes or any Tempus Pro Monitors in stock that have not been distributed, do not distribute them. Modify the response form to include your firm's contact information and then send the response form along with the customer correction notice to customers. If you need any further information or support contact the firm at (800) 722-9377 or email [email protected]. On 11/6/23, updated correction notices were distributed adding two additional models that could become affected if their hardware is updated. Additionally, the notices asked customers to install software (V07.34) on Tempus Pro Monitors according to installation instructions.

Recall details

Recall number
Z-2625-2023
Status
Open, Classified
Initiated by the company
Aug 24, 2023
Posted by the FDA
Sep 21, 2023
Recalling firm
Remote Diagnostic Technologies Ltd.
Quantity
3,524
Product code
MHX
FDA submissions
K201746
Distribution
US:AZ, AL, CA, CO, DC, DE, FL , GA, HI, IA, ID, IL, IN , KS, KY, MA , MD , ME, MI, MN, MO, MS, MT, NC , ND, NE, NJ, NM , NV, NY, OH, OK, OR, PA, TN, TX, UT, VA , WA, WI, WV, WY. OUS: AE, AT, AU, BE, BN, BO, CA, CH, CZ, DE, DK, ES, FR, GB, HK, IE, IL, IS, IT, KY, LU, MY, NL, NO, OM, PT, RO, SA, SE, SG, SI, TH, YT, ZA

Product description

Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, and 00-1007, when Used With Tempus Pro Video Laryngoscope, REF 01-2044

Code information (models, lots, serial numbers)

Monitors with hardware version: Trizeps-7, and software versions v07.26 through v07.30. REF/UDI-DI: 00-1004-R/05060472440020, 05060472442901; 00-1007-R/05060472440013, 05060472442918; 00-1024-R/05060472441027, 05060472442925; 00-1026-R/05060472441058, 05060472442932; 00-1004/05060472440624; 00-1007/05060472440655

Devices named in this recall

10 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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