Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 16, 2020
Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usage: designed using the latest programming technology and is easy to install and to use.
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Spacelabs Healthcare, Ltd. recalled Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usage: designed using the latest … - a moderate-severity action.
Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usage: designed using the latest … was recalled by Spacelabs Healthcare, Ltd. in December 16, 2020. Reason: During system upgrade incorrect comments may be added to existing tests. In such instance: Resting ECG and AB…. Check the official notice for the remedy. Verify recall #Z-0563-2021 with the FDA Devices before acting.
The recall
Spacelabs Healthcare, Ltd. issued this moderate-severity FDA Devices recall-During system upgrade incorrect comments may be added to existing tests. In such instance: Resting ECG and AB….
- Moderate
- severity level
- 600 units
- affected scope
- Class II
- classification
- December 16, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0563-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0563-2021) was formally reported on December 16, 2020, with the manufacturer initiating the action on November 6, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Spacelabs Healthcare, Ltd. is listed as the recalling firm, operating out of Hertford, N/A. Federal records list the affected scope as 600.
The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: 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…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Where this recall sits in the database
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
600
Related Recalls
6
0 from same agency
Product description
Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usage: designed using the latest programming technology and is easy to install and to use.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0563-2021 |
| Date reported | December 16, 2020 |
| Date initiated | November 6, 2020 |
| Recalling firm | Spacelabs Healthcare, Ltd. |
| Firm location | Hertford, N/A |
| Affected scope | 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… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0563-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usage: designed using the latest programming technology and is easy to install and to use.. Recalled by Spacelabs Healthcare, Ltd.. Units affected: 600.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 16, 2020. Severity: Moderate. Recall number: Z-0563-2021.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0563-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported December 16, 2020.
- Source: FDA - Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC - Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA - National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.