Philips Recalls Nuclear Gamma Cameras Due to Collimator Misalignment
Philips Medical Systems is recalling 975 nuclear gamma cameras because the collimator exchange carriage and storage cabinet were misaligned.
What this means for you
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 injuries, illnesses, or hospitalizations, and the defect is a mechanical misalignment rather than a high-risk pathogen or structural failure causing immediate harm.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 975 units of nuclear gamma cameras, including the ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60, and ADAC CARDIO C60 models. These devices are intended to produce images depicting the anatomical distribution of radioisotopes in the human body for interpretation by medical personnel.
The recall was initiated after the firm was notified by a customer that the collimator exchange carriage and the collimator storage cabinet were misaligned. The affected units were distributed nationwide in the United States and in various countries worldwide, including Australia, Canada, China, France, Germany, Japan, and the United Kingdom.
Healthcare facilities should identify affected units by checking the model and serial numbers listed in the official recall notice. The FDA classifies this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Nuclear gamma cameras (ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60 & ADAC CARDIO C60) Nuclear gamma cameras intended to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by medica
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 975
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)
- VERTEX PLUS/SOLUS/CARDIO Model #88297
- Serial #s: 9504103
- 9703171
- 9802304
- 9809124
- 9809415
- 9810438
- 9910015
- 9911711
- _0002032
- 0007001M
- 0008009B
- 0011002B
- 0101002C
- 0102019V
- 0103020V
- 01069VM
- 01070VM
- 0111001V
- 01295VM
Distribution
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