| Date Initiated by Firm | October 28, 2024 |
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| Date Posted | November 26, 2024 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0557-2025 |
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| Recall Event ID |
95642 |
| 510(K)Number | K200849 |
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| Product Classification |
Dc-defibrillator, low-energy, (including paddles) - Product Code LDD
|
| Product | Tempus LS-Manual Defibrillator Model 00-3020
The Tempus LS-Manual is a defibrillator that can deliver a shock in manual or Pacemaker mode |
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| Code Information |
Model Number: 00-3020
UDI-DI code: 07613365002737
Serial Numbers:
7022.000367
7022.000387
7022.000392
7022.000462
7022.000463
7022.000464
7022.000559
7022.000591
7022.000595
7022.000711
7022.000781
7022.000786
7022.00108
7022.001175
7022.001201
7022.00129
7022.001556
7022.001582
|
Recalling Firm/
Manufacturer |
Remote Diagnostic Technologies Ltd.
Farnborough Aerospace Centre
Aerospace Boulevard
Farnborough United Kingdom
|
| For Additional Information Contact | Philips Customer Services
800-722-9377 |
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Manufacturer Reason
for Recall | Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number. |
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FDA Determined
Cause 2 | Labeling Change Control |
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| Action | On 10/28/2024, Philips sent an "URGENT Medical Device Correction" Letter via Certified Mail to customers informing them that SCHILLER AG, the manufacturer of the Tempus LS Manual Defibrillator, informed Philips that the incorrect labels were supplied with the service kit (kits 3, 6 and 8). The affected labels can be identified by the wrong device name (TEMPUS LS instead of TEMPUS LS MANUAL), the wrong CAT number (00-3010 instead of 00-3020) and the additional CE marking. SCHILLER AG initiated a correction on 10/07/2024.
Customers are instructed to:
Share this recall notice with those who need to be aware within their organization and any organization where the potentially affected devices have been transferred. It is recommended that the recall notice be posted on or near affected systems as a constant reminder of the issue until it is corrected.
A Philips representative will contact affected customers to arrange for the corrected labels to be affixed to the affected Tempus LS Manual Defibrillators.
For questions or assistance, contact Philips at 1-800-722-9377 or email ECR.Recall.Repsonse@Philips.com |
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| Distribution | U.S. Nationwide distribution in the states of AL, CA, FL, MO, NY, OH, TX and VA. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = LDD
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