Recall Z-1990-2014— Siemens Healthcare Diagnostics, Inc.
Class II · Terminated
Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2014-06-02, terminated 2015-12-23. It names one FDA 510(k) clearance: K911400. Product: MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge. Siemens Healthcare Diagnostics, Inc. in vitro diagnostic. 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..
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-06-02
- Terminated
- 2015-12-23
- Firm location
- West Sacramento, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge. Siemens Healthcare Diagnostics, Inc. in vitro diagnostic
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.