Medical DeviceMay 8, 2019
Randox Laboratories G-6-PDH Deficient Control (G-6-PDH CONTROL D), Catalogue Number PD2617 recall — FDA Z-1254-2019
The target values and ranges in these lots are incorrect.
Class IIFDA: TerminatedRandox Laboratories Ltd.
May 2019 recalls — page 13
These records include useful source details for the selected month.
Medical DeviceMay 8, 2019
GE Healthcare Discovery NM 630 Product Usage: The Discovery NM 630 is an all-purpose dual recall — FDA Z-1257-2019
During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one…
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceMay 8, 2019
Bard Medical Division Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads: Description, Catalog recall — FDA Z-1241-2019
Specific lots of ArcticGel Pads have potential issues which may result in the insufficient adhesion of the hydrogel to the pad.
Class IIFDA: TerminatedBard Medical Division
Medical DeviceMay 8, 2019
GE Healthcare Discovery NM/CT 670 ES Product Usage: The GE Discovery NM/CT 670 system is a recall — FDA Z-1260-2019
During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one…
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceMay 8, 2019
GE Healthcare Discovery NM/CT 670 CZT, Model/Catalogue/Code H3906CT Product Usage: The GE recall — FDA Z-1258-2019
During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one…
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceMay 8, 2019
Viewray MRIdian Linac Radiation Therapy System, Model 20000 recall — FDA Z-1251-2019
A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and AQA dose calculations can occur.
Class IIFDA: TerminatedViewray, Inc.
Medical DeviceMay 8, 2019
DePuy Spine Concorde Lift, Lordotic Expandable Interbody Device, spinal fusion implant 9x23 recall — FDA Z-1226-2019
A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants.
Class IIFDA: TerminatedDePuy Spine, Inc.
Medical DeviceMay 8, 2019
PerkinElmer Life and Analytical Sciences AutoDELFIA hCG Kit, In Vitro Diagnostic for the recall — FDA Z-1238-2019
hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.
Class IIFDA: OngoingPerkinElmer Life and Analytical Sciences, Wallac, OY
Medical DeviceMay 8, 2019
DePuy Spine Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 recall — FDA Z-1225-2019
A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants.
Class IIFDA: TerminatedDePuy Spine, Inc.
Medical DeviceMay 8, 2019
Lin-Zhi International Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF recall — FDA Z-1256-2019
Shelf life of the product may be reduced due to degradation of the assay.
Class IIIFDA: TerminatedLin-Zhi International Inc.
Medical DeviceMay 8, 2019
GE Healthcare NM/CT 850 Product Usage: The GE NM/CT 850 system is intended for general recall — FDA Z-1262-2019
During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one…
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceMay 8, 2019
Siemens Medical Solutions USA SOMATOM Definition Edge, Model Number 10590000 Product Usage recall — FDA Z-1245-2019
Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners with a…
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceMay 8, 2019
GE Healthcare NM/CT 860 Product Usage: The GE NM/CT 860 system is intended for general recall — FDA Z-1263-2019
During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one…
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceMay 8, 2019
PerkinElmer Life and Analytical Sciences DELFIA hCG Kit, In Vitro Diagnostic for the recall — FDA Z-1237-2019
hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.
Class IIFDA: OngoingPerkinElmer Life and Analytical Sciences, Wallac, OY
Medical DeviceMay 8, 2019
Matrix Surgical Holdings OMNIPORE Surgical Implant Petite Paranasal - Right - Product Usage recall — FDA Z-1224-2019
Product mislabeling.
Class IIFDA: TerminatedMatrix Surgical Holdings, LLC
Medical DeviceMay 8, 2019
Siemens Medical Solutions USA SOMATOM Confidence, Model Number 10590100 Product Usage recall — FDA Z-1244-2019
Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners with a…
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceMay 8, 2019
Philips Medical Systems Nederlands Ingenia Ambition S (781359), Ingenia Ambition X (781356) recall — FDA Z-1240-2019
Magnet Energization Device (MED) can have a residual voltage on output terminal, may cause electrical shocks to personnel servicing the MED, MDD or connected cabling.
Class IIFDA: TerminatedPhilips Medical Systems Nederlands
Medical DeviceMay 8, 2019
Carolina Liquid Chemistries CAROLINA(R) LIQUID CHEMISTRIES CORP recall — FDA Z-1253-2019
Supplier testing showed that the absorbance rate of the Ethyl Alcohol Assay did not meet internal quality control specifications. The defective lots will not function toward the end of…
Class IIIFDA: TerminatedCarolina Liquid Chemistries
Medical DeviceMay 8, 2019
BioFire Diagnostics FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire recall — FDA Z-1242-2019
Elevated rates of false positive results for Campylobacter and Cryptosporidium have been identified.
Class IIFDA: TerminatedBioFire Diagnostics, LLC
Medical DeviceMay 8, 2019
GE Healthcare NM 830 Product Usage: The Discovery NM 630 is an all-purpose dual detector recall — FDA Z-1261-2019
During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one…
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceMay 8, 2019
Siemens Healthcare Diagnostics Atellica IM aTG (500 test kit) Siemens Material Number (SMN) recall — FDA Z-1236-2019
Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit lots ending in 316 and lower and Atellica IM aTG kit lots ending in 317 and lower when compared to the standardization to World…
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Medical DeviceMay 8, 2019
GE Healthcare Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for recall — FDA Z-1266-2019
During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one…
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceMay 8, 2019
GE Healthcare Discovery NM/CT 670 DR Product Usage: The GE Discovery NM/CT 670 system is a recall — FDA Z-1259-2019
During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one…
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceMay 8, 2019
Philips Fetal Spiral Electrode, Model No. 9898 031 37631 recall — FDA Z-1250-2019
During use of the Philips FSE, it is possible for the metal electrode tip to break off and remain in the scalp of the newborn following labor and delivery.
Class IIFDA: TerminatedPhilips North America, LLC
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.