Spacelabs Healthcare, Ltd. 2024-12-25 Health serious FDA
Health · FDA · Recall #FDA-Z-0684-2025
Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter… Recall
Issued December 25, 2024 · Spacelabs Healthcare, Ltd.
In December 2024, Spacelabs Healthcare, Ltd. recalled the Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Spacelabs Healthcare, Ltd. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Spacelabs Healthcare, Ltd.
- Category
- Health
- Recall date
- December 25, 2024
- Units affected
- Not reported
- Sold at
- 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
- Recall number
- FDA-Z-0684-2025
- Made in
- United Kingdom
- Issuing agency
- FDA
In context
- Spacelabs Healthcare, Ltd. has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.