Z-0563-2021Class II

Sentinel V10.x & V11.x, Models: 98200 & 98201 -

Name: Z-0563-2021 Sentinel V10.x & V11.x, Models: 98200 & 98201 -
Creator: Spacelabs Healthcare, Ltd.
Published: 2020-11-06
License: https://open.fda.gov/license/

GE Healthcare / initiated 2020-11-06 / Terminated / root cause: software

FDA source

Spacelabs Healthcare, Ltd. began a recall of Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usage: designed using the latest programming technology and is easy to install and to use on 2020-11-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0563-2021
Classification: Class II
Status: Terminated
Initiated: 2020-11-06
Posted: 2020-12-10
Terminated: 2024-10-18
Recalling firm: GE Healthcare
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.
Product code: DQK Computer, Diagnostic, Programmable
Reason for recall: 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 tag: software
FDA 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 [email protected]
Quantity in commerce: 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.
Product codes and lots: Systems that have been upgraded from Version 9 or below to Version 10 or above.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0563-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0563-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-16	2020-12-10

Product code DQK

K152881Class IISentinel Cardiology Information Management SystemSpacelabs Healthcare, Ltd. / cleared 2016-04-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)