FDA Medical Device Recalls (openFDA)
Remote Diagnostic Technologies Ltd.: Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual
- Recall number
- Z-2028-2024
- Recalling firm
- Remote Diagnostic Technologies Ltd.
- Product
- Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual
- Status
- Open, Classified
- Initiated
- 2024-05-09
- Posted
- 2024-06-06
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Labeling design
- Action
- On 5/9/24, Philips distributed correction notices to customers and distributors asking them to do the following: 1) The User/Operator Manual was updated can be downloaded by searching "Tempus LS-Manual User-Operator Manual" at Philips.com/IFU 2) This notice needs to be shared with those who need to be aware within your organization and any organization where the potentially affected devices have been transferred. 3) Complete and return the response form via email to ECR.Recall.Response@Philips.com. The following URL can also be used to complete/return the response form: https://philips.efrnfeedback.com/se/705E3ED80E91C689
- Quantity
- 1745
- Distribution
- 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.
- Lot, serial or model codes
- 00-3020: UDI-DI-07613365002737, Serial Numbers prior to 7022.002871 User/Operator Manual Versions: 41-3007EN-01 and prior
- 510(k) numbers
- ["K200849"]
- PMA numbers
- not on file
- Product code
- LDD
- Firm FEI
- 3003832357
- Firm city
- Farnborough
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28