The M220 optics may unintentionally drop into the surgical field, risking contact with the patient.
All Recalls
95,064 total recalls in our database
Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP31 Product Usage: The PRISMAFLO IIS warmer is used for warming return blood flow.
Stihler Electronic Gmbh
PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result in a hotspot on the Heating Profile, may cause low level skin burn
Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
There is an anomaly with the Eclipse(TM) Treatment Planning System [TPS] Proton Convolution Superposition [PCS] dose calculation algorithm. The PCS algo- rithm calculates the water equivalent range incorrectly for non-square 3D CT images (either different number of pixels in X and Y, or non-square pixels). Before the dose is calculated, Eclipse resamples the CT images to create a calculation image with a maximum resolution of 256 x 256. The PCS algorithm assumes uniform resolution in X and Y directions, or that X = Y for all images, and erroneously sets the Y = X for dose calcu- lation. For images that are not square, where either X<>Y, or the length of X does not equal the length of Y, the computed water equivalent range R is erroneous compared to the correct range R: 1) X=Y; R =R (R is correct); 2) X<Y: R <R (R is too small) and 3) X>Y R >R (R is too big).
Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP33 Product Usage: The PRISMAFLO IIS warmer is used for warming return blood flow.
Stihler Electronic Gmbh
PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result in a hotspot on the Heating Profile, may cause low level skin burn
Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
The firm had a report of doctors being unable to pull the obstetric forceps apart.
Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
Perfusion Pack, Rx only, Sterile EO
LivaNova USA
4-way stopcocks and stopcock manifold assembled in certain perfusion tubing systems, indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours, may leak or be occluded.
BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter, REF D134301 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation.
Stryker Sustainability Solutions
Stryker s Sustainability Solutions division (SSS) has received an increase in reports indicating that an EEPROM chip error code may occur when Reprocessed 2515 NAV eco Variable Electrophysiology (EP) Catheters are used with CARTO(R) EP Navigation Systems.
There is potential for a piece of the distal tip on the Percuvance shaft to become deformed and possibly break off during use. If a piece did break off it could compromise the functionality and security of the tool tip. Should this occur during use, surgical intervention may be required.
The firm had a report of doctors being unable to pull the obstetric forceps apart.
Heating Profile PRISMAFLO II blood return warmer for Prismaflex Product Code: PF2-WP2618 Product Usage: The PRISMAFLO IIS warmer is used for warming return blood flow.
Stihler Electronic Gmbh
PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result in a hotspot on the Heating Profile, may cause low level skin burn
The firm had a report of doctors being unable to pull the obstetric forceps apart.
The firm had a report of doctors being unable to pull the obstetric forceps apart.
Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit