Spacelabs Healthcare CardioCall ECG Event Recorder — Class II medical device recall Z-0172-2016
Terminated recall by Spacelabs Healthcare Inc, reported 2015-11-04, distributed in NE, SC, WA. When the battery is inserted into the CardioCall ECG Event Recorder, the device beeps twice and is followed by
| Recall number | Z-0172-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spacelabs Healthcare Inc, Snoqualmie, WA, United States |
| Recall initiated | 2015-09-03 |
| Classified | 2015-10-27 |
| Reported by FDA | 2015-11-04 |
| Terminated | 2016-09-07 |
| Distributed | NE, SC, WA |
| Countries outside the US | AE, AU, BE, BO, CA, CL, DE, DK, GB, GT, HK, IT, NL, NZ, PL, PT, QA, SG, TR |
| Serial numbers | CARD-200990, CARD-201287, CARD-623478, CARD-623775, CARD-624198, CARD-624224, CARD-624314, CARD-624387, CARD-624404, CARD-624413, CARD-624891, CARD-625061, CARD-625089, CARD-625124, CARD-625232, CARD-625269, CARD-625296, CARD-625304, CARD-625322, CARD-625421 |
| Model numbers | ST80, ST80X4, VS20, VS20X4 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0172-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.