Spacelabs CardioCall ECG Event Recorders Recalled for Battery Defect
Spacelabs Healthcare is recalling CardioCall ECG Event Recorders because a battery defect causes continuous ringing and prevents normal operation.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the defect results in a functional failure (device will not operate normally) without reported injuries or immediate physical harm, fitting the criteria for moderate severity.
Plain-English summary
Spacelabs Healthcare Inc is recalling specific models of the CardioCall ECG Event Recorder, including VS20, VS20x4, ST80, and ST80x4. The recall involves 275 devices and 113 printed circuit board assemblies (PCBAs) distributed worldwide, with US distribution in Nebraska, South Carolina, and Washington.
The recall is due to a defect where the device fails its self-test when a battery is inserted. This causes the device to beep twice and then emit a continuous ringing sound that only stops when the battery is removed. As a result, the device will not operate normally to record electrocardiogram data.
Patients using these devices should stop using them and contact their healthcare provider or Spacelabs Healthcare for instructions on replacement or repair. The affected units are identified by specific serial numbers and PCBAs PN # 670-1670-00.
The recalled product
- 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.
- Manufacturer
- Spacelabs Healthcare Inc
- Category
- Medical Device — Cardiology
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- PCBAs PN #: 670-1670-00. SERIAL NUMBERS in the US: 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
- and CARD-625421. SERIAL NUMBERS OUTSIDE THE US: CARD-000019
Distribution
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