Stryker Medical has identified that on some units of the MTA7900, there is a lack of a water temperature display while the unit is in Auto mode. While in Auto mode, only the patient temperature is displayed along with the set point. The water display will be blank during Auto mode. If the user wants to see the water temperature displayed and switches out of Auto mode to Manual mode, then back to
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Infusion Pumps
🏥 Medical Devices • 4,350 recalls
Class I - Dangerous
Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Class I - Dangerous
Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Class I - Dangerous
Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Class I - Dangerous
Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
CP5 centrifugal pump system Product Usage: The Stockert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.
Sorin Group Deutschland GmbH
Class I - Dangerous
Sorin is initiating a field correction on S5/C5 Heart-lung machine and CP5 centrifugal pump system due to reports of pump speed control knob failures resulting in no response.
Class I - Dangerous
Product may contain a cannula with an active tip length of only 5mm rather than 10mm as indicated on the label.
Class I - Dangerous
Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Class I - Dangerous
Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
When the number of fractions is changed for a proton spot beam, the MU are recomputed and rounded if necessary, but the dose is not recalculated as it should be even after saving and re-opening the plan.
Class I - Dangerous
Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other.
Class I - Dangerous
Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other.
Class I - Dangerous
Update to correct the possibility for patients or operators to have their fingers trapped or pinched between the table top and the bottom frame of the 550 TxT Treatment Table. Combined with this update instruction is a second complaint issue related to an incident in which a cable inside of the TxT" Treatment Table has been damaged due to contacting a moving part. The resulting short-circuit cau
Class I - Dangerous
Sterility of device may be compromised due to lack of pouch seal integrity
Class I - Dangerous
BD Interlink Threaded Lock Cannula REF# 303369 and lot #3021392 is being recalled due to the potential that a small percentage of the lot may exhibit open seals which adversely impacts unit package integrity and product sterility.
Class I - Dangerous
Sterility of device may be compromised due to lack of pouch seal integrity
Class I - Dangerous
Sterility of device may be compromised due to lack of pouch seal integrity
Class I - Dangerous
Sterility of device may be compromised due to lack of pouch seal integrity
Class I - Dangerous
Sterility of device may be compromised due to lack of pouch seal integrity
Class I - Dangerous
Product did not reach expected sterility assurance level