Recall archive
353 recalls · page 8 of 15
Reported Jun 13, 2018
Centricity PACS-IW with Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare
Matched: Brand — Potential that one or more image series may be missing from an exam without a user warning displayed in the Viewer.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 25, 2018
GE Healthcare Lunar: a) DPX Duo, Model Number: LU41693 b) DPX Bravo, Model Number: LU41692 Provides an estimate of BMD…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
Matched: Brand · Product · Product details — Under certain conditions, when using DICOM Worklist along with DICOM MPPS, a report for a bone density exam may be sent to PACS with the incorrect…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 11, 2018
Uterine Electromyographic Monitor - Monica Novii Wireless Patch System Product Usage: The Novii Interface is an…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — if the cables of the Monica Novii System are removed by a user, and then incorrectly re-connected the Fetal Heart Rate (FHR) and Maternal Heart Rate…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 11, 2018
GE Healthcare Centricity PACS-IW, Model Numbers: (a) 2052831-00X (b) 2049588-008 Product Usage: Centricity PACS-IW by…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare
Matched: Brand · Product · Product details — A database handling error could occur during the image acquisition process affecting the completeness of acquired images with Centricity PACS-IW.…
FDA (openFDA device enforcement)
Reported Apr 4, 2018
DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER Is designed for the metered delivery of specific inhalation anesthetic agents…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 7, 2018
GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2 The CARESCAPE Central Station is intended to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems Information Technologies, Inc.
Matched: Brand · Product · Product details — CARESCAPE Central Station (CSCS) software version 2.0.2 units may experience unexpected NO COMM (No Communication) and network communication issues…
FDA (openFDA device enforcement)
Reported Jan 24, 2018
Fellows "Mighty 8" Power strip (Part Number 04175-0008) and TrippLite Power strip (PS-415-HGULTRA - Part Number…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand — Merge is conducting a hardware recall (replacement) of Fellows "Mighty 8" Power Strip and TrippLite Power Strip due to overheat of input resistor…
FDA (openFDA device enforcement)
Reported Sep 13, 2017
Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand · Product · Product details — The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.
FDA (openFDA device enforcement)
Reported Jul 26, 2017
Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution for the display, management, archive,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand — When the user has not set up any user preference on the sorting order to render the study images (OS/OD/etc.) and reports, the ECP may get an…
FDA (openFDA device enforcement)
Reported Jul 19, 2017
Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — Carestation 620, 650 and 650c has Potential for Elevated FiCO2 and Unexpected System Malfunction
FDA (openFDA device enforcement)
Reported Jul 19, 2017
The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo software.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand — If the PDM is utilized to output a pressure for computing fractional flow reserve (FFR), the analog output may not reflect the true representation of…
FDA (openFDA device enforcement)
Reported Jul 12, 2017
Multiphor II Electrophoresis System GE HealthCare Product Number: 18-1018-06 PerkinElmer Part Number: 2117-004 Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Perkinelmer Life Sciences, Inc.
Matched: Product · Product details — Potential for electric shock in the case of a failure to install the grommets, supplied with the system.
FDA (openFDA device enforcement)
Reported Jul 5, 2017
Merge LIS software. The firm name on the label is Merge Healthcare. Merge LIS system is a complete system for ordering,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand · Product · Product details — There are potential issues with results reporting for certain run-based tests. Under certain conditions, the wrong results could inadvertently be…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 28, 2017
Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand · Product · Product details — Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 21, 2017
GE Healthcare Revolution EVO X-ray system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details — It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
16 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 21, 2017
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand · Product · Product details — Merge PACS did not show unviewed images when the last view was skipped. There is a potential risk to health of a physician misdiagnosis because not…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 7, 2017
Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — Reported incidents of a patient step detaching from the table. A fall from a patient step detaching while in use could result in an injury to a…
FDA (openFDA device enforcement)
Reported May 31, 2017
Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to be used to acquire,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand · Product · Product details — Fetal patient report was automatically pulling prior measurement data for a prior fetus since the fetal study is based on the mother's MRN, resulting…
FDA (openFDA device enforcement)
Reported May 10, 2017
Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number HW-HEMO-00001. The PhaseIn Unit is an optional…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand — The units may display the alarm "sampling line clogged" after the flow zeroing procedure that is conducted automatically 1 hour after start up. This…
FDA (openFDA device enforcement)
Reported Apr 26, 2017
Merge Eye Station and Merge Eye Care PACS.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand — During an antivirus program scan of the Eye Station or Eye Care PACS, the antivirus program may detect a newly captured image to be an unwanted file…
FDA (openFDA device enforcement)
Reported Apr 19, 2017
Vivid E95/E90/E80, H45581DC, H45581LB and H45581DA.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Reason for recall — GE Healthcare has become aware of an issue where a patient other than the intended is incorrectly selected by the operator in situations where DICOM…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 19, 2017
Centricity PACS Web Diagnostic (WebDX) by GE Healthcare Dynamic Imaging Solutions is a device that receives medical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ge Medical Systems Information T
Matched: Brand · Product · Product details — It was reported from a complaint that study category labels of "Prior" and "Baseline" and hanging position appeared incorrectly swapped when the…
FDA (openFDA device enforcement)
Reported Apr 19, 2017
iConnect Enterprise Archive (ICEA) software. The firm name on the labeling is Merge Healthcare, Hartland, WI.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand · Product · Product details — An error message can occur resulting in the prior studies being unavailable for viewing.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 5, 2017
Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand — The system will completely stop allowing the downloading or acquisition of new images due to incompatible software application versions.
2 more products in this recall
FDA (openFDA device enforcement)
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