🏥 Medical Devices • 6,627 recalls
Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m) Beam quality --(1) Half-value layer (HVL), which was revised in 2006. Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006.
Cartridges are leaking. The leaking is observed when opening the wrapper that holds the reagent cartridge.
There is a variation of reticulocyte counts between XE Series (XE-2100, XE-5000) and XT-Series (XT-2000i, XT-4000i) hematology analyzers that may result in a retic counts that are an average of 21% lower on the XE-Series because of a low bias.
A patient was seriously mistreated after a user made and saved an inadvertent change to the definition of a treatment filed in MOSAIQ.
Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Vital Images has found two potential errors in calcium score values in restored snapshots of studies generated through use of Vitrea or Vitrea Enterprise Suite. This issue affects Version 3.1 of Vitrea fX; Version 5.2 of Vitrea; Versions 6.0, 6.1 and 6.2 of Vitrea and Vitrea fX; and Versions 1.3, 6.0, 6.1 and 6.2 of Vitrea Enterprise Suite; and all updates to those versions.
It was identified that BRAF controls dispositioned as "Internal Use Only" were incorrectly packaged into cobas 4800 BRAF V600 Mutation Test CE-IVD kit lot R03607 and released for distribution. Two control batches manufactured during two process validation studies are involved: PV7711: BRAF Mutant (MUT) Control PV0853: BRAF Wild Type (WT) Control
BR Assay for CA 27.29 Calibration Interval Change due quality control (QC) results outside of the expected ranges.
Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
The firm recalled due to higher reactivity with some samples in the effected lots, which may reflect a higher false positive rate.
Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
It was discovered of a potential failure of the spectral filter mechanism inside the collimator of the innova 3100, innova 3100-IQ and innova 3131-IQ systems.