Medical equipment, implants, and diagnostic devices
Siemens Healthcare Diagnostics
Siemens Dimension LOCI TNI Troponin I calibrator lot 3DD007 may demonstrate an average upward shift of 24% in QC and patient results following calibration.
Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
Philips Medical Systems
For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.
Siemens Medical Solutions USA
There is a potential risk when using LANTIS OIS System client software with operating systems for which it has not been validated and released, resulting in incorrectly stored data, such as treatment records, and LANTIS database corruption.
The Anspach Effort
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
The Anspach Effort
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
The Anspach Effort
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
Siemens Medical Solutions USA
When using systems operating with software versions VD10A/G during a RAD examination, a malfunction can result in the image appearing very dark, which may prompt unnecessary repetition of the examination.
SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
VARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH
Anomaly with the ProBeam System where under certain conditions, the Treatment Control and Monitoring application could fail to send treatment history records to the ARIA database.
Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
The Anspach Effort
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
Surface finish is different than specified. The implant has 30 grit blast on the exterior of the flange when the print calls for the glass bead blast. The patient may experience pain requiring surgical intervention.
During routine inspection, beaded hip stem forgings received from supplier failed to meet ZES 2A-102. Processing of Beaded CoCrMo Alloy Hip Stem, material requirements per ATS #14-04818 and ATS #14-05549, respectively.
SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
Near Point Chart Arm of RT 5100 and RT-3100 Refractors may lower spontaneously with potential for patient injury.
SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
Intuitive Surgical
In some procedures when using the endoscope in conjunction with the IS4000 (da Vinci Xi) System, the surgical view has an orange-yellow tint which can make it hard to differentiate between tissue
The Anspach Effort
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.