Reason: Lack of 510(k) clearance.
Distributed: US Nationwide distribution.Reason: Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reduction
Distributed: Worldwide - US Nationwide distribution.Reason: Product may be potentially contaminated with a lubricant used during the manufacturing process.
Distributed: US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.Reason: Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reduction
Distributed: Worldwide - US Nationwide distribution.Reason: Product may be potentially contaminated with a lubricant used during the manufacturing process.
Distributed: US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.Reason: Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.
Distributed: US Nationwide distribution in the states of North Carolina, and California.Reason: Product may be potentially contaminated with a lubricant used during the manufacturing process.
Distributed: US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.Reason: A software issue may result in unintended mismatch of patient information on manually printed images. Incorrect patient information appearing on printed images could create a documentation discrepancy or incorrect association of clinical images with a patient record.
Distributed: Worldwide - US Nationwide and the countries of Australia, Canada, New Zealand.Reason: Product may be potentially contaminated with a lubricant used during the manufacturing process.
Distributed: US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.Reason: Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Distributed: Worldwide - Nationwide and the country of Canada.