SIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, Emission
Summary
The FDA issued a Class II for SIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, Emission by Siemens Medical Solutions USA, Inc.. Reason: This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position..
Details
Source
Device Recall
External ID
Z-1134-2023
Action Date
2023-02-22
Status
Ongoing
Category
device
Product Description
SIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, Emission
Lot/Code Info: UDI/DI 405686901102894792, Material Number 10532746, Serial Number 94792
Quantity Affected: 1 unit
Reason for Recall
This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.
Distribution
Worldwide distribution - US Nationwide and the countries of Japan, Chile, Australia.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-01-16
Company
Hoffman Estates, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 157 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Siemens Medical Solutions USA, Inc. has 277 FDA actions in our database, including 173 recalls and 104 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Siemens Medical Solutions USA, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Siemens Medical Solutions USA, Inc. have FDA actions?
Siemens Medical Solutions USA, Inc. has 277 FDA actions in our database, including 173 recalls and 104 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1134-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29