CLASS II ONGOING Device recall · Reported 27 Sep 2023 · FDA Enforcement Report
Philips Tempus Pro Patient Monitor recalled
Remote Diagnostic Technologies is recalling Philips Tempus Pro Patient Monitor, distributed in 42 states. The recall was initiated on 24 Aug 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2625-2023
- FDA event ID
- 92914
- Recalling firm
- Remote Diagnostic Technologies, Farnborough
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Aug 2023
- FDA classified
- 21 Sep 2023
- Reported
- 27 Sep 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Patient Monitors
Timeline
| 24 Aug 2023 | Recall initiated by company | |
| 21 Sep 2023 | Classified by FDA | +28 days |
| 27 Sep 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
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
Where it was distributed
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
AlabamaArizonaCaliforniaColoradoDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyMassachusettsMarylandMaineMichiganMinnesota
Questions about this recall
Why was it 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.
Which lots are affected?
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
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Remote Diagnostic Technologies
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Philips Tempus Pro Patient Monitor recalled | Remote Diagnostic Technologies | Other | Nationwide |
| Device | CLASS II | Inseego USB8 Dongle Kit recalled by Remote Diagnostic Technologies | Remote Diagnostic Technologies | Device Malfunction | Nationwide |
| Device | CLASS II | Philips Tempus Pro Patient Monitor recalled | Remote Diagnostic Technologies | Labeling Errors | Nationwide |
| Device | CLASS II | Tempus Pro Patient Monitor, REFs recalled | Remote Diagnostic Technologies | Device Malfunction | Nationwide |
| Device | CLASS III | Tempus LS-Manual Defibrillator recalled | Remote Diagnostic Technologies | Labeling Errors | Nationwide |
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| Device | CLASS I | Bravo CF capsule delivery device, Product Number FGS recalled | Given Imaging | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | IQecg Digital ECG recalled by Midmark | Midmark | Labeling Errors | Nationwide |