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U.S. Department of Health and Human Services

Class 2 Device Recall Eclipse PRO

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 Class 2 Device Recall Eclipse PROsee related information
Date Initiated by FirmNovember 25, 2024
Date PostedDecember 17, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0684-2025
Recall Event ID 95786
510(K)NumberK211651 
Product Classification Electrocardiograph, ambulatory (without analysis) - Product Code MWJ
ProductEclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory electrocardiogram.
Code Information Model Number: 98700 UDI-DI code: 10841522128851 Serial Numbers: All serial numbers manufactured between April 2021 to November 2024. Serial Numbers pending.
Recalling Firm/
Manufacturer		 Spacelabs Healthcare, Ltd.
Unit B
Foxholes Centre; John Tate Road
Hertford United Kingdom
For Additional Information ContactZachary Orlowski
425-396-3300
Manufacturer Reason
for Recall		Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter recorder. The physical serial number label on the device might not match the serial number programmed into the device.
FDA Determined
Cause 2		Process control
ActionOn 11/25/2024, the firm sent an "URGENT MEDICAL DEVICE CORRECTION" Letter to customers inform them that the Eclipse Pro and Eclipse MINI cardiac Holter monitors may have mismatched serial numbers between the label and what is programmed in the devices. This is due to a manufacturing error. Customers are instructed to: complete the following steps for each Eclipse device under your control. Following these steps will allow you to check if your device is affected. 1. Visit https://eclipseutils.cardiology.spacelabs.com/ 2. The first time you use this site you will need to register for an account. Click Register and create a username and password. 3. Plug Eclipse (Mini or Pro) device into the computer via USB. 4. Select Serial Check in the menu and click CONNECT NEW RECORDER 5. Select the device from the list and click Connect 6. Click VERIFY SERIAL NUMBER once the device is connected 7. When prompted, enter the serial number printed on the label of the device and click CONTINUE 8. If the serial number you entered on the website does not match the serial number loaded into the device, you will see the warning. Confirm that you do not have a typo in the serial number you entered on the website. If you have a typo, click GO BACK . If correctly entered the serial number click CONFIRM . 9. If the serial number entered on the website matches the serial number loaded into the device, you will see the confirmation below. Confirm that you do not have a typo in the serial number you entered on the website. If you have a typo, please click GO BACK . If you have correctly entered the serial number click CONFIRM . 10. Repeat the previous steps for all your eclipse devices. Questions or assistance - contact Spacelabs service at 1-800-522-7025 or visit us at https://spacelabshealthcare.com/support/ Follow-up Updated Customer Letter sent 04/04/2025
Quantity in Commerce13,202 devices
DistributionU.S.: AR, CA, CO, DE, FL, FA, LA, MA, MI, MN, MT, NC, NE, NU OH, OR, PA, Puerto Rico, TN, TX, UT, VA, WA, and WI. O.U.S.: Argentina Denmark Kuwait Serbia Australia Dominican Republic Lebanon Singapore Austria Ecuador Lithuania Spain Belgium El Salvador Martinique Sweden Benin France Mexico Switzerland Bolivia Germany Netherlands Taiwan Brazil Greece Oman Trinidad and Tobago Brunei Darussalam Guatemala Panama Turkey Canada Honduras Peru United Arab Emirates Chile Hong Kong Poland United Kingdom China Iceland Portugal Columbia India Venezuela Congo Ireland Qatar Viet Nam Costa Rica Israel Republic of Macedonia Croatia Italy Roumanie Czech Republic Korea, Republic of Saudi Arabia
Total Product Life CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = MWJ
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