MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge...
FDA Device Recall #Z-1990-2014 — Class II — June 2, 2014
Recall Summary
| Recall Number | Z-1990-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 2, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Siemens Healthcare Diagnostics, Inc. |
| Location | West Sacramento, CA |
| Product Type | Devices |
| Quantity | WA40: 560 US, 131 OUS, 9 already repaired; WA96: 81 US, 189 OUS, 57 repaired. |
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.
Distribution Pattern
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.
Lot / Code Information
WalkAway 40 - Material number: 10444853; catalog number: B1018-283; WalkAway 96 - Material number: 1044854, Catalog number B1018-284.
Other Recalls from Siemens Healthcare Diagnostics, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1484-2026 | Class II | Atellica CH Urine Albumin (UAlb). Material Numb... | Jan 20, 2026 |
| Z-0491-2026 | Class II | IMMULITE 2000 Oak Mix Specific Allergen; Sieme... | Oct 6, 2025 |
| Z-0492-2026 | Class II | 3gAllergy Specific IgE Universal Kit; Kit Comp... | Oct 6, 2025 |
| Z-0493-2026 | Class II | Food Panel 3 Specific Allergen; Siemens Materi... | Oct 6, 2025 |
| Z-0366-2026 | Class II | Assay: IMMULITE 2000 Intact PTH; Test Code: iP... | Sep 22, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.