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Showing 3481–3500 of 11714 results

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ST SENSE Breast Dx Coil (Philips) – patient safety issue (2024)

Potential safety issue where a patient may be harmed while preparing for or during a scan.

FDANov 4, 2024Nationwide• Philips North America Llc

SENSE Breast Coil 3.0T 7ch (Philips) – patient safety issue (2024)

Potential safety issue where a patient may be harmed while preparing for or during a scan.

FDANov 4, 2024Nationwide• Philips North America Llc

SENSE Breast Coil (Philips) – patient safety issue (2024)

Potential safety issue where a patient may be harmed while preparing for or during a scan.

FDANov 4, 2024Nationwide• Philips North America Llc

PeakMax Capsules (Boulla) – Undeclared Ingredients (2024)

Undeclared Allergen

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.

FDANov 4, 2024Nationwide• Boulla LLC

ZapMax Capsules (Boulla) – Undeclared Ingredients (2024)

Undeclared Allergen

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.

FDANov 4, 2024Nationwide• Boulla LLC

VitalityXtra Capsules (Boulla) – Undeclared Ingredients (2024)

Undeclared Allergen

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.

FDANov 4, 2024Nationwide• Boulla LLC

ZoomMax Capsules (Boulla) – Undeclared Ingredients (2024)

Undeclared Allergen

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.

FDANov 4, 2024Nationwide• Boulla LLC

Jarritos Coconut Water – Seal Compromise (2024)

The hermetic seal on the lid of the cans may be compromised

Class IIModerate

FDANov 4, 2024AL, AR, DE +26 more• Tipp Distributors, Inc. dba Novamex

Mammotrak Diagnostic Coil 1.5T (Philips) – Patient Safety Risk (2024)

Potential safety issue where a patient may be harmed while preparing for or during a scan.

FDANov 4, 2024Nationwide• Philips North America Llc

Mammotrak Interventional Coil (Philips) – Patient Safety Risk (2024)

Potential safety issue where a patient may be harmed while preparing for or during a scan.

FDANov 4, 2024Nationwide• Philips North America Llc

FACSLyric 2L4C Instrument (BD) – power supply module issue (2024)

On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, which has the potential for the instruments to fail to power on and/or stay on. The potential power supply failure on BD FACSLyric Flow Cytometer may lead to risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. The patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In addition, patient specimen loss and/ or delay providing results of testing results. There may be additional risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. In addition, the patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In the Notification Letter sent on November 20, 2024, customers are instructed to continue their normal operation of your BD FACSLyric Flow Cytometer according to the Instructions For Use after immediately inspecting inventory for the specific catalog and power supply serial numbers listed in the notification letter and follow the instructions listed under Actions for Clinical Users

FDANov 1, 2024Nationwide• Becton, Dickinson and Company, BD Bio Sciences

FACSLyric 3L12C Instrument (BD) – power supply module issue (2024)

On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, which has the potential for the instruments to fail to power on and/or stay on. The potential power supply failure on BD FACSLyric Flow Cytometer may lead to risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. The patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In addition, patient specimen loss and/ or delay providing results of testing results. There may be additional risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. In addition, the patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In the Notification Letter sent on November 20, 2024, customers are instructed to continue their normal operation of your BD FACSLyric Flow Cytometer according to the Instructions For Use after immediately inspecting inventory for the specific catalog and power supply serial numbers listed in the notification letter and follow the instructions listed under Actions for Clinical Users.

FDANov 1, 2024Nationwide• Becton, Dickinson and Company, BD Bio Sciences

Arial Server Software (Securitas) – call notification failure (2024)

Certain software versions will not notify end users of calls initiated by call points with the Arial Emergency and Nurse Call System.

FDANov 1, 2024Nationwide• Securitas Healthcare LLC

Becker External Drainage System (Medtronic) – stopcock leakage (2024)

Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).

FDANov 1, 2024Nationwide• Medtronic Neurosurgery

SMS Elastic Cuff Isolation Gown (Cardinal Health) – hydrostatic pressure failure (2024)

Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Association for the Advancement of Medical Instrumentation) Level 3 protection requirements.

FDANov 1, 2024Nationwide• Cardinal Health 200, LLC

FACSLyric 3L8C Instrument (BD) – power supply module issue (2024)

On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, which has the potential for the instruments to fail to power on and/or stay on. The potential power supply failure on BD FACSLyric Flow Cytometer may lead to risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. The patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In addition, patient specimen loss and/ or delay providing results of testing results. There may be additional risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. In addition, the patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In the Notification Letter sent on November 20, 2024, customers are instructed to continue their normal operation of your BD FACSLyric Flow Cytometer according to the Instructions For Use after immediately inspecting inventory for the specific catalog and power supply serial numbers listed in the notification letter and follow the instructions listed under Actions for Clinical Users.

FDANov 1, 2024Nationwide• Becton, Dickinson and Company, BD Bio Sciences

Kreatech PapV-16 ISH Probe (Kreatech) – DNA fragment size issue (2024)

The DNA fragments for this specific lot number are too large, resulting in potential background around the cells due to suboptimal hybridization. An absence of signal could also be observed as a result of the suboptimal hybridization of the larger DNA fragments. The user may interpret potential background as a false positive result and an absence of signal as a false negative result, if proper positive and negative controls are not included.

FDANov 1, 2024FL, NY• Kreatech Biotechnology Bv Vlierweg 20 Amsterdam Netherlands

FACSLyric 2L6C Instrument (BD) – power supply module issue (2024)

On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, which has the potential for the instruments to fail to power on and/or stay on. The potential power supply failure on BD FACSLyric Flow Cytometer may lead to risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. The patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In addition, patient specimen loss and/ or delay providing results of testing results. There may be additional risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. In addition, the patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In the Notification Letter sent on November 20, 2024, customers are instructed to continue their normal operation of your BD FACSLyric Flow Cytometer according to the Instructions For Use after immediately inspecting inventory for the specific catalog and power supply serial numbers listed in the notification letter and follow the instructions listed under Actions for Clinical Users.

FDANov 1, 2024Nationwide• Becton, Dickinson and Company, BD Bio Sciences

Exacta External Drainage System (Medtronic) – stopcock leakage (2024)

Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).

FDANov 1, 2024Nationwide• Medtronic Neurosurgery

Convertor Isolation Gown (Cardinal Health) – hydrostatic pressure failure (2024)

Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Association for the Advancement of Medical Instrumentation) Level 3 protection requirements.

FDANov 1, 2024Nationwide• Cardinal Health 200, LLC

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