CLASS II ONGOING Device recall · Reported 12 Jun 2024 · FDA Enforcement Report
Philips Tempus LS-Manual Defibrillator recalled
Remote Diagnostic Technologies is recalling Philips Tempus LS-Manual Defibrillator, distributed nationwide in the US. The recall was initiated on 9 May 2024 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-2028-2024
- FDA event ID
- 94618
- Recalling firm
- Remote Diagnostic Technologies, Farnborough, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 May 2024
- FDA classified
- 6 Jun 2024
- Reported
- 12 Jun 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Pacemakers & Defibrillators
Timeline
| 9 May 2024 | Recall initiated by company | |
| 6 Jun 2024 | Classified by FDA | +28 days |
| 12 Jun 2024 | 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
Simultaneous ECG measurements with multiple devices, including a manual defibrillator, on the same patient may cause electrical noise or interference, which may lead to distortions of the ECG signal; distortions may lead to no or ineffective pacing, or no or inappropriate defibrillation pulse.
Product as listed by the FDA
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual
Where it was distributed
US Nationwide distribution including in the states of VA, DC, MA, WY, AZ, FL, CA, NM, NJ, TN, OH, KS, IN, NY, IL, TX, NV, NE, PA, AL, IA, GA, MO, KY, WI, OR, CO, WV, WA, ET, UT, ID, OK, MN, ME, MT, MI, NC, ND, MD, DE, VT.
Nationwide AlabamaArizonaCaliforniaColoradoDistrict of ColumbiaDelawareFloridaGeorgiaIowaIdahoIllinoisIndianaKansasKentuckyMassachusettsMarylandMaineMichiganMinnesotaMissouri
Questions about this recall
Why was it recalled?
Simultaneous ECG measurements with multiple devices, including a manual defibrillator, on the same patient may cause electrical noise or interference, which may lead to distortions of the ECG signal; distortions may lead to no or ineffective pacing, or no or inappropriate defibrillation pulse.
Which lots are affected?
00-3020: UDI-DI-07613365002737, Serial Numbers prior to 7022.002871 User/Operator Manual Versions: 41-3007EN-01 and prior
Where was it sold?
US Nationwide distribution including in the states of VA, DC, MA, WY, AZ, FL, CA, NM, NJ, TN, OH, KS, IN, NY, IL, TX, NV, NE, PA, AL, IA, GA, MO, KY, WI, OR, CO, WV, WA, ET, UT, ID, OK, MN, ME, MT, MI, NC, ND, MD, DE, VT.
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 II | Medline convenience kits: Bib AV Fistula Pack DYNJ58304B recalled | Medline Industries | Device Malfunction | Nationwide |