Recall archive
59 recalls · page 2 of 3
Reported Nov 22, 2017
Symbia Intevo 16, SPECT/CT System, Emission Computed Tomography System To detect or image the distribution of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand — The Broad Quantification option of the Symbia product software version VB20A may not allow modification of two data input values. The failure occurs…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 1, 2017
Torque wrench used on the bolts for the Symbia T2 model 10275008, Symbia Intevo Excel model 10764801, Symbia Intevo 16…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand — The torque wrench used to tighten system bolts during installation was found to be out of tolerance
FDA (openFDA device enforcement)
Reported May 3, 2017
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand · Reason for recall — When scanning with the 18L6 HD transducer on the ACUSON HELX" Evolution with Touch Control, the ultrasound system may display a triple image or an…
FDA (openFDA device enforcement)
Reported Dec 7, 2016
Z6Ms transesophageal transducers used on ACUSON SC2000 ultrasound systems, Z6Ms model 10436113. Radiology: The ACUSON…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand · Product details — Firm received reports about "acquisition errors" and the deterioration of material covering the articulating section of the Z6Ms transesophageal…
FDA (openFDA device enforcement)
Reported Oct 19, 2016
Symbia S, Product Usage 1) SPECT: To Detect or image the distribution of radionuclides in the body or organ, using the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand · Product · Product details — The detectors on the Symbia S and Symbia T camera systems are supported and moved horizontally and vertically by four linear bearing cars. There is a…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 14, 2016
e.cam and Symbia E gamma camera systems with patient beds To detect or image the distribution of radionuclides in the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand · Reason for recall — "We have received reports of patients hair being caught in the e.cam and Symbia E patient bed up/down drive. The purpose of this letter is to remind…
FDA (openFDA device enforcement)
Reported May 11, 2016
ACUSON SC2000 Ultrasound imaging system with software version VB10C and using transesophageal (TEE) transducer Z6Ms,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand — While imaging with a transesophageal (TEE) transducer (Z6Ms, V5Ms, or V7M), user may lose the ability to control the color region of interest, the…
FDA (openFDA device enforcement)
Reported May 4, 2016
ACUSON X700 Ultrasound System with software version 1.0.04. Model numbers: 10658844 ACUSON X700 Ultrasound System…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand · Product details — Due to a communication error between the software and V5Ms transducers rotation function, ACUSON X700 ultrasound systems at software versions 1.1.04,…
FDA (openFDA device enforcement)
Reported Apr 6, 2016
The E.CAM gamma camera system Product Usage: The E.CAM gamma camera system is a SPECT system and measures the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand · Product · Product details · Reason for recall — We received a customer complaint that Siemens reported via the MedWatch process (1423253-2015-00002). The result of a Hazard Analysis and CAPA…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 27, 2016
The e.cam Dual Signature Gamma Camera system. Used to detect or image the distribution of radionuclides in the body or…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand — To provide operator instruction manuals for the e.cam Dual Signature; Gamma Camera that were not sent in its entirety when the e.cam systems were…
FDA (openFDA device enforcement)
Reported Nov 11, 2015
e.cam Gamma Camera, an emission computed tomography system. It is intended to detect or image the distribution of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand — Potential failure mode related to the radial brake, where the detector was able to drift, led to a re-design of the brake redundancy circuit. The…
FDA (openFDA device enforcement)
Reported Nov 4, 2015
ACUSON SC2000 ultrasound systems model 10433816 Imaging system that provides the ability to measure anatomical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand · Reason for recall — Siemens will provide all customers a new version of system software (VA35E or VB10C depending on the hardware configuration). Hardware fixes will be…
FDA (openFDA device enforcement)
Reported Sep 23, 2015
ACUSON SC2000 Ultrasound System with software versions VB10B and lower; Model 10433816; Product Usage: The SC2000…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand · Product · Product details — The ACUSON SC2000 ultrasound system considers uppercase/lowercase differences in the same patient name as unique patient instances when registered on…
FDA (openFDA device enforcement)
Reported Aug 26, 2015
Siemens Symbia S Series system, a diagnostic analog or digital detector based planar (2- dimensional) nuclear medicine…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand · Product · Product details — Fuses with the improper amperage rating were installed in the Symbia S, Symbia T Series and Symbia lntevo systems. These fuses, in conjunction with a…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 12, 2015
ACUSON S Family ultrasound systems utilizing the 18L6 HD and/or 6C1 HD biopsy guidelines 6C1HD - model numbers:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand — When using the CIVCO biopsy attachments in combination with the ACUSON S Family on-screen guidelines, the biopsy needle may traverse outside the…
FDA (openFDA device enforcement)
Reported Aug 5, 2015
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand — Potential measurement error on ACUSON S Family ultrasound system when using the Doppler manual trace measurement tool in full screen format that has…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 8, 2015
ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the Stress Echo Option. Model…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand · Product details — When performing a 2D Stress Echo study, some following keystrokes result in a potential loss of data, where some selected clips may not be saved as…
FDA (openFDA device enforcement)
Reported May 13, 2015
ACUSON SC2000 volume imaging ultrasound systems at software versions VA16C, VA16D and VA16E. Model 10433816. Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand · Product details — In some cases, the system is unable to capture a clip or image during a routine scan.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 25, 2015
Symbia E is a multi-purpose SPECT system used to detect or image the distribution of radionuclides in the body or…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand — Radial motor drives replaced during a customer service action were incorrectly assembled backwards.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 18, 2015
ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730. The affected sub-components are #10434968 -…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand — There is a low probability the scanner arm will become completely detached from the scanner column.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 11, 2015
ACUSON SC2000 Ultrasound System, Model 10433816, component 10040596 - UILK2. The SC2000 ultrasound imaging system is…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand · Product details — The bolt holding the control panel of the ACUSON SC2000 in a fixed position may fail and the Control panel cannot be locked into position.
FDA (openFDA device enforcement)
Reported Jan 21, 2015
Symbia T and Symbia T2 computer tomography systems. These systems are used to perform SPECT, CT, and SPECT + CT scans…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand — There are confirmed reports of a component coming loose inside the CT enclosure and damaging the system. components.
FDA (openFDA device enforcement)
Reported Jan 14, 2015
The Siemens Symbia S series is intended for use by appropriately trained health care professionals to aid in detecting,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand · Product · Product details · Reason for recall — Siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detectors. This unintended motion, should it occur, may…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 29, 2014
Symbia E is a multi-purpose SPECT system ideal for hospitals and outpatient centers. It is used to detect or image the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand — Reports of loose bolts in the detector support structure of Symbia and E.CAM systems.
1 more product in this recall
FDA (openFDA device enforcement)
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