Recall Z-2738-2020— Hill-Rom, Inc.
Class II · Terminated
Class II FDA medical device recall by Hill-Rom, Inc., initiated 2020-06-30, terminated 2022-10-20. FDA's recall record names no specific 510(k) clearance for this event. Product: Centrella Smart+ Bed, Catalog No. P7900 - Product Usage: intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from either Continuous Lateral Rotation Therapy or Percussion/Vibration Therapy.. Reason: Affected beds may have screws installed that do not meet material tensile strength requirements. Failure of this screw could result in serious patient or user injury..
- Recalling firm
- Hill-Rom, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-06-30
- Terminated
- 2022-10-20
- Firm location
- Batesville, IN, United States
Product description
Centrella Smart+ Bed, Catalog No. P7900 - Product Usage: intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from either Continuous Lateral Rotation Therapy or Percussion/Vibration Therapy.
Reason for recall
Affected beds may have screws installed that do not meet material tensile strength requirements. Failure of this screw could result in serious patient or user injury.
Data sourced from openFDA. This site is unofficial and independent of the FDA.