Elscint Cardial; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging Class II

Reason: GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 20250912 Ongoing
Distributed: Worldwide
Artegraft¿ Collagen Vascular Graft; REF: AG1015; Class II

Reason: The device was incorrectly packed in the wrong size labeled outer packaging.

LeMaitre Vascular, Inc. 20250925 Ongoing
Distributed: US distribution to the state of: AR
HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04J Class II

Reason: Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact.

HeartSine Technologies Ltd 20250918 Ongoing
Distributed: US Nationwide distribution. Worldwide distribution to Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Latvia, Lithuania, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom.
SM_40HF_BDC3, Mobile X-ray system Class II

Reason: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

SEDECAL SA 20250610 Ongoing
Distributed: US: CA, IL, and NJ
SM_40HF_BDC, Mobile X-ray system Class II

Reason: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

SEDECAL SA 20250610 Ongoing
Distributed: US: CA, IL, and NJ
SM_40HF_B_D_VIR3.004, Mobile X-ray system Class II

Reason: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

SEDECAL SA 20250610 Ongoing
Distributed: US: CA, IL, and NJ
SM_40HF_B_D_VIR3, Mobile X-ray system Class II

Reason: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

SEDECAL SA 20250610 Ongoing
Distributed: US: CA, IL, and NJ
SHIMADZU RF.004, Mobile X-ray system Class II

Reason: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

SEDECAL SA 20250610 Ongoing
Distributed: US: CA, IL, and NJ
SED URS LP, Mobile X-ray system Class II

Reason: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

SEDECAL SA 20250610 Ongoing
Distributed: US: CA, IL, and NJ
RADPRO MOBILE, Mobile X-ray system Class II

Reason: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

SEDECAL SA 20250610 Ongoing
Distributed: US: CA, IL, and NJ
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Data provided by openFDA