The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly flipped left/right and/or there can be patient data mismatch.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
Colpo-Pneumo Occluder, Part CPO-6
CooperSurgical
Class I - Dangerous
The seal of the sterile pouch may be compromised, thereby increasing the risk of infection.
Class I - Dangerous
Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Right, REF ZBH-PSNCRGH712-R.
Orthosensor
Class I - Dangerous
Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
Class I - Dangerous
The reason for this field action is due to the mounting of a non-tamper-resistant (ordinary) battery drawer on some BABY440 hearing aids. The correct battery drawer is tamper-resistant and require a special tool to open it.
OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, REF ZBH-PSNCREF311-R.
Orthosensor
Class I - Dangerous
Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
Class I - Dangerous
Firm received sporadic reports of discoloration on certain lots of the product, which has been identified as common mold.
Potential for the tethered plug on the hub of the NeoMed Enteral Feeding Tubes with Enteral Only Connectors to inadvertently open after closure.
Class I - Dangerous
Product marketed in U.S. does not have sufficient data to ensure that it will meet the internal burst pressure specifications at the end of 5 yrs shelf-life
Class I - Dangerous
Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
Class I - Dangerous
BioFlo Ports was partially manufactured with the incorrect sterile port assembly. The actual sterile port assembly used was, 8F SL Xcela Plus Titanium Valved Non-Filled, when it should have been, 8F SL BioFlo Plastic Valved Non-Filled
INSORB SUBCUTICULAR SKIN STAPLER, REF 2030
Incisive Surgical
Class I - Dangerous
Possible compromise of the sterile barrier integrity
Class I - Dangerous
Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
Class I - Dangerous
Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
Capnostream20 M ADULT ICU (CPM), CS08654RA
Oridion Medical 1987
Class I - Dangerous
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
Class I - Dangerous
Potential for product sterility breach due to a compromised or pinched seal defect
Bronchovideoscope BF-XP160F
Olympus Corporation of the Americas
Class I - Dangerous
The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.
VITROS Sodium Slides, Catalog # 837 9034
Ortho-Clinical Diagnostics
Class I - Dangerous
Potential for positively biased results
Class I - Dangerous
"Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
Rhino Laryngo scope ENF-VT2
Olympus Corporation of the Americas
Class I - Dangerous
The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.