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Showing 4401–4420 of 8389 results

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DJO EMPOWR Knee Punch (Unknown) – Surgical Disruption (2023)

Knee punch handle tip is breaking during surgery due to the lack of heat treatment, which may lead to a disruption in surgery.

FDASep 29, 2023AL, AZ, CA +21 more

LIFEPAK 15 (Physio-Control) – Battery Pin Looseness (2023)

Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.

FDASep 29, 2023Nationwide• Physio-Control, Inc.

LIFEPAK 15 (Physio-Control) – Battery Pin Looseness (2023)

Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.

High

FDASep 29, 2023Nationwide• Physio-Control, Inc.

LIFEPAK 15 (Physio-Control) – Battery Pin Looseness (2023)

Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.

FDASep 29, 2023Nationwide• Physio-Control, Inc.

GEM Premier 3000 PAK (Instrumentation) – pO2 Over-Recovery (2023)

Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e., positive bias) of pO2 results in the low range (at pO2 levels less than 60 mmHg) that are outside of labeled performance specifications for pO2. The positive bias may lead to false positive for medical decision levels at pO2 < 60 mmHg, which may result in failure to detect and/or adequately treat hypoxemia and lead to a delay in treatment. The quality control procedures for the Non-iQM GEM Premier 3000 may not detect the non-conformance.

FDASep 29, 2023MA, MN, NY• Instrumentation Laboratory

Alinity c Iron Reagent (Sentinel) – High Recovery Issue (2023)

A high recovery of Iron assay has been observed at some customer sites. Internal studies confirmed the positive shift of Quality Control and patient samples results, up to 15% for Iron Products (Alinity c Iron Reagent REF. 08P3920) to be used on Abbott Alinity Instrument and to 30% for Iron Products (IRON REF. 6K95-41 and IRON REF. 6K95- 30) to be used on Abbott Architect Instrument. When using the affected lots, there is a potential for delay in reporting patient results due to QC failure, also a potential for falsely elevated results.

FDASep 29, 2023Nationwide• Sentinel CH SpA Via Robert Koch

LIFEPAK 15 (Physio-Control) – Battery Pin Looseness (2023)

Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.

FDASep 29, 2023Nationwide• Physio-Control, Inc.

IRON Assay (Sentinel) – High Recovery Issue (2023)

A high recovery of Iron assay has been observed at some customer sites. Internal studies confirmed the positive shift of Quality Control and patient samples results, up to 15% for Iron Products (Alinity c Iron Reagent REF. 08P3920) to be used on Abbott Alinity Instrument and to 30% for Iron Products (IRON REF. 6K95-41 and IRON REF. 6K95- 30) to be used on Abbott Architect Instrument. When using the affected lots, there is a potential for delay in reporting patient results due to QC failure, also a potential for falsely elevated results.

FDASep 29, 2023Nationwide• Sentinel CH SpA Via Robert Koch

LIFEPAK 15 (Physio-Control) – Battery Pin Looseness (2023)

Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.

FDASep 29, 2023Nationwide• Physio-Control, Inc.

LIFEPAK 15 (Physio-Control) – Battery Pin Looseness (2023)

Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.

FDASep 29, 2023Nationwide• Physio-Control, Inc.

LIFEPAK 15 (Physio-Control) – Battery Pin Looseness (2023)

Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.

FDASep 29, 2023Nationwide• Physio-Control, Inc.

LIFEPAK 15 (Physio-Control) – Battery Pin Looseness (2023)

Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.

FDASep 29, 2023Nationwide• Physio-Control, Inc.

LIFEPAK 15 (Physio-Control) – Battery Pin Looseness (2023)

Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.

FDASep 29, 2023Nationwide• Physio-Control, Inc.

EVO+VISIAN Lens (Staar Surgical) – Specification Concerns (2023)

Their is a potential that intraocular implant devices may not meet specifications.

FDASep 29, 2023AZ, AR, CA +35 more• Staar Surgical Company

LIFEPAK 15 (Physio-Control) – Battery Pin Looseness (2023)

Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.

FDASep 29, 2023Nationwide• Physio-Control, Inc.

Tracheal Intubation Fiberscope (Olympus) – Flow Rate Issue (2023)

Fiberscopes do not have adequate data to support that the suction flow rate meets the device specification.

FDASep 28, 2023Nationwide• Olympus Corporation of the Americas

McGRATH MAC Laryngoscopes (Covidien) – Stolen Defective Units (2023)

Defective video laryngoscopes that did not pass quality tests established for the product, that were designated for destruction, were stolen, and subsequently distributed for sale. Defective device use may result in failed laryngoscopy and/or intubation.

FDASep 28, 2023Nationwide• Covidien

NT2000iX RF Generator (Abbott) – Service Tool Inaccuracy (2023)

Certain NT2000iX RF generators were serviced using a tool that was subsequently found to be out of tolerance and therefore may not have provided accurate results for potential capacitance failure.

FDASep 28, 2023Nationwide• Abbott

Journey II BCS Insert (Smith & Nephew) – Labeling Mixup (2023)

The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM.

FDASep 27, 2023Nationwide• Smith & Nephew, Inc.

Journey II BCS Insert (Smith & Nephew) – Labeling Mixup (2023)

The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM.

FDASep 27, 2023Nationwide• Smith & Nephew, Inc.

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