Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patien

FDA device recall Z-0684-2025 · posted 2024-12-17 · Open, Classified

Recall details

Recalling firm

Spacelabs Healthcare, Ltd.

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.

Action taken

On 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

Root cause

Process control

Status

Open, Classified

Product code

MWJ

Quantity affected

13,202 devices

Distribution

U.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

Date initiated

2024-11-25

Date posted

2024-12-17

Location

Hertford, United Kingdom

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