Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Rev A and Update Kit, PN: 040-1565-10. Used f

FDA device recall Z-1273-2014 · posted 2014-03-25 · Terminated

Recall details

Recalling firm

Spacelabs Healthcare, Llc

Reason for recall

Spacelabs has voluntarily recalled G2 Clinical Access Software CD because the programs installed on the Clinical Access CD are incorrect and it will prevent the customer from installing Clinical Access.

Action taken

Spacelabs Healthcare began sending out the Medical Device Correction letter, dated 28 February 2014, to domestic customers on 28 February 2014 and to international customers by 7 March 2014. The letter identified the product, the product, the problem, and the action to be taken by the customer. Customers are also directed to call 1-800-522-7025 and select 2 for Technical Support. Customers are advised to dispose the CD, PN: 063-1829-11 Rev A previously supplied and replace it with the replacement CD (Rev B) provided.

Root cause

Labeling Change Control

Status

Terminated

Product code

DQK

Quantity affected

36 units total: 17 units were distributed in the US and 19 units distributed outside the US.

Distribution

Worldwide Distribution- USA (nationwide) including the states of Alabama, Florida, Georgia, Louisiana, Missouri, New York, South Carolina, Tennessee, Texas and Wyoming, and the countries of Australia,

Date initiated

2014-02-14

Date posted

2014-03-25

Date terminated

2014-05-20

Location

Snoqualmie, WA

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