Recall Z-1273-2014 ยท DQK Computer, Diagnostic, Programmable
Spacelabs Healthcare, Llc
Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Rev A and Update Kit, PN: 040-1565-10. Used for installing ICS G2 Clinical Access software onto hospital personal computers.
| Date | Mar 25, 2014 (initiated Feb 14, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Labeling Change Control |
| Action | 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. |
| Quantity | 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, Canada, Czechoslovakia, China, Colombia, France, Great Britain, Italy, Netherlands, Poland, Saudi A |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110779 | SPACELABS SMART DISCLOSURE SYSTEM Spacelabs Healthcare, Apr 19, 2011 |