U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Lift, patient, non-ac-powered - Product Code FSA
원인
Complaints (including one reported death) allegedly of the lift arm drifting down suddenly. if the lift arm assembly is manually lifted, the actuator can become damaged and get stuck in the highest position. if a patient is lifted into the sling while the actuator is stuck, there is a potential risk of a free fall of the patient, resulting in minor or potentially catastrophic injuries.
조치
On 3/20/2015, URGENT Field Safety Notice notifications, dated 3/19/2015 were sent to US customers by e-mail and or courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers are forward a copy of the letter to any other appropriate facility personnel. Additionally, the attached form should be completed and returned to Hill-Rom. Upon receipt, the firm will contact customers to schedule an inspection of the potentially affected devices. For questions, call 800-445-3720 (Mon - Thurs, 8 am - 6:30 pm; Friday, 8 am - 6 pm).
Worldwide Distribution -- AE, AO, AR, AT, AU, AZ, BD, BE, BG, BH, BR, CA, CH, CL, CN, CO, CS, CZ, DE, DK, EG, ES, FI, FR, GR, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JO, JP, KR, KW, LB, LI, LT, LU, LV, MA, MT, MX, MY, NL, NO, NZ, OM, PH, PL, PT, QA, RO, SA, SE, SG, SI, SK, SY, TH, TN, TR, TW, UK, US, VE, and ZA.
제품 설명
Viking M, L, and XL Mobile Lifts. || Non-AC-powered patient lift.