Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usage: designed using the latest programming technology and is easy to install and to use.
This recall has been terminated (originally issued November 6, 2020).
- Recall Initiated
- November 6, 2020
- Terminated
- October 18, 2024
- Recall Number
- Z-0563-2021
- Quantity
- 600
- Official Source
- View on FDA website ↗
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.
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 / Code Info
Systems that have been upgraded from Version 9 or below to Version 10 or above.
Root Cause
Software design
Action Taken
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