Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 4, 2015
Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4, PCBAs PN # 670-1670-00 Product Usage: The CardioCall event recorder is worn by the patient to record a short period of electrocardiogram which can be sent to his physician.
When the battery is inserted into the CardioCall ECG Event Recorder, the device beeps twice and is followed by a continuous ringing sound that only stops when battery is removed. …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Spacelabs Healthcare Inc recalled Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4, PC… - a moderate-severity action.
Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4, PC… was recalled by Spacelabs Healthcare Inc in November 4, 2015. Reason: When the battery is inserted into the CardioCall ECG Event Recorder, the device beeps twice and is followed b…. Check the official notice for the remedy. Verify recall #Z-0172-2016 with the FDA Devices before acting.
The recall
Spacelabs Healthcare Inc issued this moderate-severity FDA Devices recall-When the battery is inserted into the CardioCall ECG Event Recorder, the device beeps twice and is followed b….
- Moderate
- severity level
- 275 units
- affected scope
- Class II
- classification
- November 4, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0172-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0172-2016) was formally reported on November 4, 2015, with the manufacturer initiating the action on September 3, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Spacelabs Healthcare Inc is listed as the recalling firm, operating out of Snoqualmie, WA. Federal records list the affected scope as 275 devices (20 in US and 255 international) and 113 PCBAs (international only).
The documented reason for this recall is: When the battery is inserted into the CardioCall ECG Event Recorder, the device beeps twice and is followed by a continuous ringing sound that only stops when battery is removed. The device has a self-test failure and w… Distribution data in the federal record shows the product reached: Worldwide Distribution - US Distribution in the states of Nebraska, South Carolina, and Washington and in the following countries of AUSTRALIA, BELGIUM, BOLIVIA, CANADA, CHILE, DENMARK, GERMANY, GUATEMALA, HONG KONG, I…. 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, 3 from FDA Devices - 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 - 40,322 medical devices recalls on record
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
275 devices (20 in US and 255 international) and 113 PCBAs (international only)
Related Recalls
6
3 from same agency
Product description
Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4, PCBAs PN # 670-1670-00 Product Usage: The CardioCall event recorder is worn by the patient to record a short period of electrocardiogram which can be sent to his physician.
Reason for recall
When the battery is inserted into the CardioCall ECG Event Recorder, the device beeps twice and is followed by a continuous ringing sound that only stops when battery is removed. The device has a self-test failure and will not operate normally.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0172-2016 |
| Date reported | November 4, 2015 |
| Date initiated | September 3, 2015 |
| Recalling firm | Spacelabs Healthcare Inc |
| Firm location | Snoqualmie, WA |
| Affected scope | 275 devices (20 in US and 255 international) and 113 PCBAs (international only) |
| Distribution | Worldwide Distribution - US Distribution in the states of Nebraska, South Carolina, and Washington and in the following countries of AUSTRALIA, BELGIUM, BOLIVIA, CANADA, CHILE, DENMARK, GERMANY, GUATEMALA, HONG KONG, ITALY, NETHERLANDS, N… |
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-0172-2016) 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? ▼
Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4, PCBAs PN # 670-1670-00 Product Usage: The CardioCall event recorder is worn by the patient to record a short period of electrocardiogram which can be sent to his physician.. Recalled by Spacelabs Healthcare Inc. Units affected: 275 devices (20 in US and 255 international) and 113 PCBAs (international only).
Why was this product recalled? ▼
When the battery is inserted into the CardioCall ECG Event Recorder, the device beeps twice and is followed by a continuous ringing sound that only stops when battery is removed. The device has a self-test failure and will not operate normally.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 4, 2015. Severity: Moderate. Recall number: Z-0172-2016.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Distribution in the states of Nebraska, South Carolina, and Washington and in the following countries of AUSTRALIA, BELGIUM, BOLIVIA, CANADA, CHILE, DENMARK, GERMANY, GUATEMALA, HONG KONG, ITALY, NETHERLANDS, NEW ZEALAND, POLAND, PORTUGAL, QATAR, SINGAPORE, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0172-2016) 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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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 4, 2015. 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.