FDA Medical Device Recalls (openFDA)
Remote Diagnostic Technologies Ltd.: Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020
- Recall number
- Z-1825-2023
- Recalling firm
- Remote Diagnostic Technologies Ltd.
- Product
- Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020
- Status
- Open, Classified
- Initiated
- 2023-05-08
- Posted
- 2023-06-12
- Terminated
- not on file
- Reason
- Defibrillator/pacemaker module (DPM) may encounter a problem causing communication from the Mainboard to the DPM to fail, leading to no or ineffective pacing with displayed error message "HW failure DPM".
- Root cause
- Device Design
- Action
- On 5/8/23, Philips mailed correction notices to customers who were asked to do the following: Potential risks associated with partial or complete failure of the device, should a patient be involved, will be mitigated by immediately starting CPR/ chest compressions in case of device dysfunction/failure. Philips will contact to arrange for the device to be returned for rework. A loner device will be provided during the time of the rework. 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. Complete and return the Customer/Distributor Reply Form: https://philips.efmfeedback.com/se/705E3ED8496AFDF8/ https://philips.efmfeedback.com/se/705E3ED8496AFDF8 Customers/Distributors who need further information or support can contact RDT.Recall.Response@Philips.com, or 1 800 722 9377 In addition, distributors were asked to forward the correction notice to their customers. The notice should be modified to include the distributor's contact information.
- Quantity
- 1147
- Distribution
- US Nationwide distribution in the states of UT, CO, CA, NE, IL, TX, WV, KS, GA.
- Lot, serial or model codes
- UDI-DI: 07613365002737. Serial numbers prior to 7022.001634
- 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