The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2205-2015·Announced 2015-07-29

Philips Recalls Head Holders Shipped with Ingenuity CT Systems

Philips Medical Systems is recalling 66 head holders shipped with Ingenuity CT systems because they were not qualified for use on this specific model.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a qualification issue where a component was not yet approved for the specific system, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 66 units of the Head Holder (M/N 4535 671 11331) that were shipped with Ingenuity CT Computed Tomography X-ray Systems. The recall is being conducted because the specific head holder model was released for use with other CT systems but had not yet been qualified for use on the Ingenuity CT system.

The affected head holders were distributed worldwide. In the United States, they were shipped to 33 states, including AR, AZ, CA, CO, CT, FL, GA, IA, IN, KS, LA, MA, MD, MI, MO, MS, NC, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA, WV, and WY. The products were also shipped to 34 countries, including Argentina, Australia, Bangladesh, Belgium, Brazil, Bulgaria, China, Colombia, Denmark, Ecuador, France, Germany, India, Indonesia, Israel, Japan, Latvia, Libya, Myanmar, Norway, Oman, Poland, Republic of Korea, Russian Federation, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, and Viet Nam.

The recall is classified as Class II by the FDA. No specific injuries or illnesses have been reported in the source text. Healthcare facilities should stop using the affected head holders with Ingenuity CT systems and contact Philips Medical Systems for further instructions on replacement or remediation.

The recalled product

Product
Head Holder shipped with Ingenuity CT Computed Tomography X-ray Systems
Manufacturer
Philips Medical Systems (Cleveland) Inc
Category
Medical Device — Imaging Equipment
Hazard
Affected units
66

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Head Holder M/N 4535 671 11331. Ingenuity CT M/N 728326
  • Serial #s: 6617
  • 10607
  • 10689
  • 32000
  • 300043
  • 300064
  • 300068
  • 300071
  • 300072
  • 300073
  • 300074
  • 300075
  • 300076
  • 300077
  • 300078
  • 300079
  • 300080
  • 300081
  • 300082

Distribution

Distributed in 32 states:

Part of a larger recall action

This product is one of 3 recalled by Philips Medical Systems (Cleveland) Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Philips Medical Systems (Cleveland) Inc

See all →

Same hazard · unqualified component

See all →

Similar recalls