Reported Nov 4, 2015 · Terminated

Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4, PCBAs PN # 670-1670-00 Product…

Spacelabs Healthcare Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Spacelabs Healthcare Inc · 35301 SE Center St · Snoqualmie, WA · 98065-9216

Is this the product you have?

Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4, PCBAs PN # 670-1670-00
Product UsageThe CardioCall event recorder is worn by the patient to record a short period of electrocardiogram which can be sent to his physician

Lot codes and dates: 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
255 of 255 codes
CARD-000019
CARD-000028
CARD-000037
CARD-000046
CARD-000064
CARD-000073
CARD-000073
CARD-000082
CARD-000091
CARD-000109
CARD-000118
CARD-000127
CARD-000136
CARD-000145
CARD-000163
CARD-000172
CARD-000181
CARD-000190
CARD-000208
CARD-000217
CARD-000226
CARD-000235
CARD-000244
CARD-000271
CARD-000280
CARD-000299
CARD-000307
CARD-000325
CARD-000334
CARD-000343
CARD-000352
CARD-000361
CARD-000370
CARD-000398
CARD-000406
CARD-000415
CARD-000424
CARD-000433
CARD-000442
CARD-000451
CARD-000479
CARD-000479
CARD-000488
CARD-000497
CARD-000505
CARD-000514
CARD-000523
CARD-000532
CARD-000550
CARD-000578
CARD-000596
CARD-000604
CARD-000613
CARD-000622
CARD-000631
CARD-000640
CARD-000659
CARD-000668
CARD-000677
CARD-000686
Amount recalled: 275 devices (20 in US and 255 international) and 113 PCBAs (international only)

Where it was sold

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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By hazard

Medical device recalls

Other recalls from Spacelabs Healthcare Inc.

16 in total.

Where it was distributed

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