Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07

FDA device recall Z-1824-2014 · posted 2014-06-18 · Terminated

Recall details

Recalling firm

Spacelabs Healthcare Inc

Reason for recall

Spacelabs Healthcare is voluntarily recalling the Hamilton Galileo Ventilator Flexport, Model 90436A-07, where the monitored Minute Volumes (Vmin) has been reported at one time to reach ten times the actual value on the bedside monitor.

Action taken

Spacelabs changed their strategy for updating the software and sent the updated letter Urgent-Medical Device Correction- Hamilton Galileo Ventilator Flexport Model 90436A-07, dated 10 June 2015, to their consignees. The firm is going to send consignees new replacement flexport(s) with upgraded software and requested consignees to return old affected units via Return Goods Authorization (RGA) to Spacelabs and the firm will destroy affected units. Consignees are instructed to take the following actions: 1. Please replace the affected devices and test for correct operation. 2. Return your old device(s) using the RGA number and prepaid FedX shipping label. Use the Reference code: and FedEx Return number: RETURN ADDRESS: Spacelabs Healthcare, Inc. 35301 SE Center St. Snoqualmie, WA 98065 (425) 363-5816 If you have any questions about this corrective action program, please call Spacelabs Healthcare at (800) 522-7025 and select 2 for Technical Support. ********************************************************************************************** Spacelabs recommends that customers immediately advise their staff of this situation and if they continue to use the Flexport, to please keep in mind: 1) Galileo Interface Protocol (GIP) version 1.0 and 1.1 do not affect the flexport readings. Only GIP version 1.2 is an issue. 2) If you have the GIP version 1.2: -The ventilator alarms continue to work normally at the bedside and central station. -The ventilator itself is available and working correctly. -The reported x10 volumes would be an obvious error to the clinician. Spacelabs Field Service personnel will be contacting all customers to schedule a convenient time to install, at no cost, a software update that resolves this issue.

Root cause

Component change control

Status

Terminated

Product code

DQA

Quantity affected

46 units distributed within the US; 108 units distributed outside the US.

Distribution

Worldwide Distribution-USA (nationwide) including the states of AZ, IN, LA, GA, SC, FL, and NY, and 18 customers outside the US.

Date initiated

2014-05-09

Date posted

2014-06-18

Date terminated

2015-11-16

Location

Snoqualmie, WA

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