FDA Medical Device Recalls (openFDA)
Spacelabs Healthcare, Ltd.: Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usage: designed using the latest programming technology and is easy to install and to use.
- Recall number
- Z-0563-2021
- Recalling firm
- Spacelabs Healthcare, Ltd.
- Product
- Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usage: designed using the latest programming technology and is easy to install and to use.
- Status
- Terminated
- Initiated
- 2020-11-06
- Posted
- not on file
- Terminated
- 2024-10-18
- Reason
- During system upgrade incorrect comments may be added to existing tests. In such instance: Resting ECG and ABP tests which did not contain comments at the time of the upgrade, may have unrelated comments added. Existing comments will not be overwritten or removed. Rhythm ECG Tests may have comments overwritten with unrelated comments. Any tests created after the upgrade are not affected.
- Root cause
- Software design
- Action
- On 11/06/20, Urgent Medical Device Correction notices were mailed to customers. Customers were asked to do the following: Any comments associated with ABP, Resting, or Rhythm tests that existed in your system prior to the date of your upgrade should be reviewed for accuracy before being used to inform any clinical decision. Weigh the benefits versus the risks when deciding whether to use the comments associated with ABP, Resting, or Rhythm tests which existed in your system prior to the date of your upgrade of Sentinel. We recommend that you brief your staff regarding the issue listed above. Complete and return the customer reply form or use the following link to acknowledge receipt of this letter: https://www.spacelabshealthcare.com/support/recall-reply-form/ For additional information or technical assistance, please contact: Global Technical Support at, +44 (0) 1992 507740, or gtsdc@spacelabs.com
- Quantity
- 600
- Distribution
- Worldwide distribution - U.S. Nationwide distribution including in the states of PR, MN, NE, FL, IL, CA, NY, ND, AR, WI, SD, TN, MO, MA, TX, MT, OH, MI, IA, NJ, CT, NC, UT, WV, GA, CO, PA, AL, DC, NV, DE, WA, OR, IN, SC, HI, MS, KS, ID, MD, LA, NH, VA, ME, AK, VT, OK, AZ, KY, NM, RI and the countries of AFGHANISTAN, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHAMAS, BELGIUM, BOLIVIA, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, FRANCE, GERMANY, GREECE, GUATEMALA, HONG KONG, ICELAND, INDIA, IRAN, IRELAND, ISRAEL, ITALY, KENYA, KOREA, REPUBLIC OF, KUWAIT, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, MEXICO, MOROCCO, NETHERLANDS, NICARAGUA, OMAN, PAKISTAN, PALESTINE, PANAMA, PARAGUAY, PERU, POLAND, PORTUGAL, QATAR, Republic of Macedonia, SAUDI ARABIA, Serbia, SINGAPORE, Slovakia, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VENEZUELA.
- Lot, serial or model codes
- Systems that have been upgraded from Version 9 or below to Version 10 or above.
- 510(k) numbers
- ["K152881"]
- PMA numbers
- not on file
- Product code
- DQK
- Firm FEI
- 3002807992
- Firm city
- Hertford
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28