| Date Initiated by Firm | September 12, 2025 |
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| Date Posted | October 16, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0166-2026 |
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| Recall Event ID |
97612 |
| 510(K)Number | K241556 |
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| Product Classification |
Electrocardiograph - Product Code DPS
|
| Product | Cardiac Workstation 7000;
Model Number: 860441; |
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| Code Information |
Model Number: 860441;
UDI-DI: 00884838094833;
Serial Numbers: US42520284, US32520248, US32520244, US22520238, US22520221;
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Recalling Firm/
Manufacturer |
Philips North America
222 Jacobs St
Cambridge MA 02141-2296
|
| For Additional Information Contact | Philips Customer Services
800-722-9377 |
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Manufacturer Reason
for Recall | Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short. |
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FDA Determined
Cause 2 | Process control |
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| Action | On September 12, 2025 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers.
Actions to be taken: Share this communication with all clinical staff to review and undedrstand. Please this letter with the device. Pass the notice along to all those who need to be aware within the organization or to any organization where affected devices were transferred. Ensure technical solution established by Philips is implemented as soon as available within the timeframe communicated by Philips. In case any device cannot be corrected, inform Philips of the reason why the Technical Solution could not be implemented.
Action By Philips: A Philips representative will contact customers to arrange a replacement of the device's hardware on affected devices with the pinched power module wire within the housing of the Cardiac Workstation. |
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| Quantity in Commerce | 29 units |
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| Distribution | US Nationwide distribution in the states of CA, IA, TN, TX, 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 = DPS
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