Recall Z-1990-2014 ยท LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Siemens Healthcare Diagnostics, Inc.
MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge. Siemens Healthcare Diagnostics, Inc. in vitro diagnostic
| Date | Jul 2, 2014 (initiated Jun 2, 2014) |
| Status | Terminated |
| Reason | Springs contained in the access door hinge assembly on the Walk Away Plus instruments are becoming detached causing premature failure of the hinge assembly and a potential safety issue for the customers. |
| Root cause | Component design/selection |
| Action | Urgent Medical Device Recall notification letter was sent to all affected US customers on June 2nd by Federal Express. OUS notifications were also sent to regional Siemens organizations who distributed in-country notifications and relevant notifications. |
| Quantity | WA40: 560 US, 131 OUS, 9 already repaired; WA96: 81 US, 189 OUS, 57 repaired. |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Algeria Argentina Brazil Canada China Chile Columbia France Indonesia Libya Georgia Germany India Italy Japan Kazakhstan Lithuania Oman Pakistan Peru Poland Portugal Republic of Korea Romania Russia Saudi Arabia Spain Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K911400 | WALKAWAY TM 40 Baxter Healthcare Corp, Nov 19, 1991 |