Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Mi

FDA device recall Z-0008-2015 · posted 2014-10-21 · Terminated

Recall details

Recalling firm

Respironics California Inc

Reason for recall

A failure of a specific component may prevent the ventilators from operating on AC power or transitioning back to AC power when operating on battery. Additionally, if a battery is not present or is depleted the ventilators will not operate. This failure will cause the loss of ventilator support, which may result in hypercarbia or hypoxemia.

Action taken

Philips Healthcare sent an Urgent - Field Safety Notice dated September 17, 2014, to all customers who purchased the Esprit V1000 and V200 Ventilators to inform them that Respironics is recalling Esprit V1000 and V200 Ventilators installed with 3rd Generation Power Supplies and also 3rd Generation Power Supply Repair Part Kits. The letter identifies the affected devices, informs the customers of the problems, hazard involved, and the actions to be taken. Customers were reminded to be advised of the warnings provided. A Philips Respironics representative will contact customers to schedule a no-cost replacement for further information or support. Customers with questions were instructed to contact Philips Healthcare at 1-800-722-9377. For questions regarding this recall call 760-918-7300.

Root cause

Unknown/Undetermined by firm

Status

Terminated

Product code

CBK

Quantity affected

2,206 units total (665 units in US)

Distribution

Worldwide Distribution - USA, Argentina, China, Egypt, Ethiopia, Honduras, Hong Kong, India, Indonesia, Iraq, Israel, Italy, Jordan, Libyan Arab Yamahiriya, Malaysia, Mali, Mexico, Myanmar (Burma). Ne

Date initiated

2014-09-17

Date posted

2014-10-21

Date terminated

2016-09-28

Location

Carlsbad, CA

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