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ZOLL MEDICAL RECALL OF PD1200 AND D900 DEFIBRILLATORS

This article was originally published in The Gray Sheet

Executive Summary

ZOLL MEDICAL RECALL OF PD1200 AND D900 DEFIBRILLATORS affects approximately 200 units shipped about a year ago, the company says. The firm sent letters on June 15 to approximately 600 customers informing them of the recall and "a potential failure of the unit[s] to charge." The letter tells operators of the emergency-use defibrillators that defective relays manufactured by an independent vendor can cause the devices to be "rendered inoperative." Customers are instructed to determine whether the relay is stamped with one of four faulty lot codes. If it is, users may either ship devices to Zoll for repair or request the manufacturer to send them new relays, so that they can replace the defective parts themselves. Zoll says it decided to recall the products after it learned of several recent device failures in the field. The letter to customers states that the relay lots had been contaminated and that the units had gradually broken down, "causing premature failure of the relay." The firm adds that it is not aware of any injuries caused by the defibrillator failures.
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