Catalog Number FL28EX |
Device Problem
Incorrect Measurement (1383)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.12 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.2 devices were not evaluated and no cause was determined, as the customers did not make the devices accessible for testing.1 device is pending evaluation.There was no remedial action taken.This device is not labeled for single use.
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Event Description
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This report summarizes 15 malfunction events, where it was reported the devices experienced incorrect measurement.There was no patient involvement.
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Manufacturer Narrative
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1 device was not evaluated, as a probable cause for the issue was identified during a troubleshooting call between the customer and stryker technical support and no further assistance was requested by the customer.Section h codes have been updated.
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Event Description
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This report summarizes 15 malfunction events, where it was reported the devices experienced incorrect measurement.There was no patient involvement.
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Search Alerts/Recalls
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