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Showing 4601–4620 of 8389 results

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V60/V60 Plus Ventilator (Philips Respironics) – power management failure (2023)

Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of function.

FDAAug 25, 2023CA, OH, OR +1 more• Philips Respironics, Inc.

AZUR CX 35 Peripheral Coil System (MicroVention) – packaging seal problem (2023)

Peripheral coil system detachable has a potential of unsealed pouch packaging.

FDAAug 24, 2023Nationwide• MICROVENTION INC.

Philips Tempus Pro Monitor (Remote Diagnostic) – screen error issue (2023)

Full screen error message may occur on patient monitors with affected hardware version, either during or after laryngoscopes are unplugged from monitors, informing users a 60-100 second shutdown/restart are required. Error prevents: viewing graphical patient vital signs, sounding of pulse audio tone, visualization of patient airway used during intubation; may lead to treatment delay or hypoxia.

High

FDAAug 24, 2023AL, AZ, CA +39 more• Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom

Medical Products Pallets (Inmar) – storage contamination risk (2023)

Various medical devices potentially exposed to rodent and rodent activity. In addition, medical devices may have been subjected to temperatures in excess of storage requirements on product labeling.

FDAAug 24, 2023Nationwide• Inmar Supply Chain Solutions, LLC

LFS Flat Screen Arm (DKK Dai-Ichi) – stopper block issue (2023)

The stopper block on the LFS bracket could be broken or missing. Without this stopper block, the flat screen attached to the LFS flat screen system can rotate beyond the original angle limit and it could cause excessive force to be given to the spring shaft of the LFS bracket. Due to the excessive force given to the spring shaft, the spring shaft could break and shear off.

FDAAug 23, 2023MI• DKK Dai-Ichi Shomei Co., Ltd. 1 Chome 32-26 Sakashita Itabashi Japan

Cinchlock SS Anchor Inserter (Stryker) – expired product distribution (2023)

Expired Product distributed

FDAAug 23, 2023Nationwide• Stryker Corporation

MINISCAV Vacuum Pump (RA Medical) – documentation inadequacy (2023)

Inadequate documentation of acceptance activity

FDAAug 23, 2023OH• R A Medical Services Holmes House Skipton Road Keighley United Kingdom

LFS Flat Screen Support Arm (DKK Dai-Ichi) – stopper block issue (2023)

The stopper block on the LFS bracket could be broken or missing. Without this stopper block, the flat screen attached to the LFS flat screen system can rotate beyond the original angle limit and it could cause excessive force to be given to the spring shaft of the LFS bracket. Due to the excessive force given to the spring shaft, the spring shaft could break and shear off.

FDAAug 23, 2023MI• DKK Dai-Ichi Shomei Co., Ltd. 1 Chome 32-26 Sakashita Itabashi Japan

Therascreen KRAS RGQ PCR Kit (Qiagen) – Handbook Revision Issue (2023)

Handbook Revision (Rev13) a dilution step is indicated as an Action when having the Flag SAMPLE_INT_CTRL_FAIL. A dilution of CRC tissue could lead to a false negative result. To remove ambiguity, an alteration must be made to the S the sample result with this flag should be interpreted as invalid

FDAAug 22, 2023Nationwide• Qiagen GmbH Qiagen Str. 1 Hilden Germany

Puritan Bennett Cuff Pressure Manager (Covidien) – power port fixation issue (2023)

Inadequate internal fixation of the power inlet port to the cuff pressure manager device causes the external power inlet to became dislodged within the device housing after several uses, which prevents the device from being charged, and could lead to treatment delay.

FDAAug 22, 2023AL, AZ, CA +13 more• Covidien

3M Attest Biological Indicator (3M) – Multiple Lot Defects (2023)

Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5 Steam-Plus Challenge (41482V, 41482VF), and 3M Attest Super Rapid Readout Steam Challenge (1496V) may contain biological indicators with a cap that melts, deforms and/or cracks following a steam sterilization cycle of 132C and 135C.

FDAAug 22, 2023Nationwide• 3M Company Health Care Business 3m Center

Palindrome Chronic Catheter Kit (Unknown) – Incorrect Length (2023)

Some catheter kits labeled as 23 cm implant length incorrectly included catheters of 28 cm implant length; the actual catheter implant length is identifiable based upon the correct labeling on the catheter body.

FDAAug 22, 2023Nationwide

3M Attest Steam Challenge Pack (3M) – Multiple Lot Defects (2023)

Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5 Steam-Plus Challenge (41482V, 41482VF), and 3M Attest Super Rapid Readout Steam Challenge (1496V) may contain biological indicators with a cap that melts, deforms and/or cracks following a steam sterilization cycle of 132C and 135C.

FDAAug 22, 2023Nationwide• 3M Company Health Care Business 3m Center

EMPOWR 3D Knee Tibial Insert (Unknown) – Surgical Parts Swap (2023)

Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs Knee).

FDAAug 22, 2023Nationwide

Reverse Prosthesis Shoulder System (Unknown) – screw size mismatch (2023)

Reverse shoulder prosthesis package that should contain 5mmx30 screws could contain incorrect 3.5mmx30 screws. Use of incorrect screws could result in surgical delay and inadequate fixation.

FDAAug 22, 2023AZ, FL, IN +11 more

Smiths Medical Portex Bivona Tracheostomy Tube (Smiths Medical) – Incorrect Expiration (2023)

The unit box is labeled with an incorrect expiration date (the manufacturing date of 3/17/2021) but the individual packaging contains the correct expiration date (3/17/2026).

FDAAug 22, 2023AZ, CA, FL +15 more• Smiths Medical ASD Inc.

EMPOWR Acetabular System Liner (Unknown) – Surgical Parts Swap (2023)

Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs Knee).

FDAAug 22, 2023Nationwide

Apellis Injection Kit (Apellis) – Needle Characteristic Deviation (2023)

19-gauge x 1" inch filter needles showed appearances of a small fraction of non-preferred characteristics. A causal relationship has not been established between the structural variations in this 19-gauge filter needle and the rare events of retinal vasculitis

FDAAug 22, 2023Nationwide• Apellis Pharmaceuticals, Inc.

Constellation Vision System (Alcon) – Circuit Board Risk (2023)

Laceration Risk

Ophthalmic microsurgical vision systems have a new Printed Circuit Board (PCB) design that could lead to higher voltage to a PCB component, that could cause component failure and loss of pressure control for the use of cutters, scissors, and forceps, which could lead to an increased risk of microbial infection, tissue damage and progressive visual impairment.

FDAAug 18, 2023GA, IL, PR• Alcon Research, LLC

Gladiator Wrist Orthosis (North Coast Medical) – Undeclared Latex (2023)

The thumb strap of the wrist and thumb orthosis may contain latex that is not declared in the product labeling.

FDAAug 18, 2023CA, NC, WI• North Coast Medical Inc

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