Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0172-2016·Announced 2015-11-04

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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: functional-failure

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

Distributed in 3 states:

Same manufacturer · Spacelabs Healthcare Inc

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