| Class 2 Device Recall Sentinel |  |
Date Initiated by Firm | November 06, 2020 |
Create Date | December 10, 2020 |
Recall Status1 |
Terminated 3 on October 18, 2024 |
Recall Number | Z-0563-2021 |
Recall Event ID |
86753 |
510(K)Number | K152881 |
Product Classification |
Computer, diagnostic, programmable - Product Code DQK
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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. |
Code Information |
Systems that have been upgraded from Version 9 or below to Version 10 or above. |
Recalling Firm/ Manufacturer |
Spacelabs Healthcare, Ltd. Unit B Foxholes Centre; John Tate Road Hertford United Kingdom
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Manufacturer 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.
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FDA Determined Cause 2 | 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 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = DQK
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