Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Biograph Horizon a) 3R, Material Number 10532746 b) 4R, Material Number 10532748 The Siemens...

FDA Device Recall #Z-0177-2019 — Class II — September 28, 2018

Recall Summary

Recall Number Z-0177-2019
Classification Class II — Moderate risk
Date Initiated September 28, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Siemens Medical Solutions USA, Inc.
Location Hoffman Estates, IL
Product Type Devices
Quantity 78 units

Product Description

Biograph Horizon a) 3R, Material Number 10532746 b) 4R, Material Number 10532748 The Siemens Biograph Horizon and Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

Reason for Recall

The terminals on the plug may become loose and overheat.

Distribution Pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Austria, Australia, Azerbaijan, Belgium, Bulgaria, Brunnel, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Dominican Rep, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Republic Korea, Lebanon, Sri Lanka, Macedonia, Mexico, Malaysia, Netherlands, Norway, New Zealand, Oman, Poland, Portugal, Paraguay, Qatar, Romania, Russian Fed, Saudi Arabia, Singapore, Slovenia, Slovakia, Spain, South Africa, Switzerland, Thailand, Turkey, Taiwan, UAE, United Kingdom and Vietnam.

Lot / Code Information

a) Material Number 10532746 Serial Numbers: 94427 94405 94408 94445 94463 94401 94432 94415 94421 94429 94436 94440 94448 94464 94464 94466 94476 94484 94406 94430 94434 94451 94483 94485 94409 94413 94414 94420 94422 94423 94424 94425 94426 94431 94435 94438 94441 94442 94443 94444 94452 94459 94460 94473 94477 94480 94481 94482 94487 94433 b) Material Number 10532748 Serial Numbers: 94500 94449 94454 94470 94404 94417 94428 94465 94472 94478 94456 94419 94471 94410 94412 94418 94446 94453 94475 94479 94416 94455 94486 94450 94411 94402 94407 94489

Other Recalls from Siemens Medical Solutions USA, Inc.

Recall # Classification Product Date
Z-3217-2024 Class II ACUSON Maple 1.0 Diagnostic Ultrasound System, ... Aug 15, 2024
Z-3215-2024 Class II ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ul... Aug 15, 2024
Z-3216-2024 Class II ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasoun... Aug 15, 2024
Z-1599-2024 Class II ACUSON Juniper Diagnostic Ultrasound System, RE... Feb 23, 2024
Z-1601-2024 Class II ACUSON Maple Diagnostic Ultrasound System, REF:... Feb 23, 2024

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.

More from Siemens Medical Soluti... Recalls by Firm Recall Reasons Device Safety Stats