Recall Z-0563-2021 ยท DQK Computer, Diagnostic, Programmable
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.
| Date | Nov 6, 2020 |
| Status | Terminated |
| 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. |
| 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 countrie |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152881 | SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM Spacelabs Healthcare, Ltd., Apr 1, 2016 |